Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-12 @ 4:18 AM
Study NCT ID:
NCT02407756
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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 Trial 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': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.', 'description': 'Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \\[8 weeks after the last dose). Analysis was performed on SAF.', 'eventGroups': [{'id': 'EG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dupilumab 4 mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Dupilumab 4 mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period), then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Allergic oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, 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'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia areata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Solar dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.91', 'spread': '2.15', 'groupId': 'OG000', 'lowerLimit': '2.15'}, {'value': '14.3', 'spread': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9'}, {'value': '23.1', 'spread': '8.71', 'groupId': 'OG002', 'lowerLimit': '8.71'}, {'value': '32.4', 'spread': '7.04', 'groupId': 'OG003', 'lowerLimit': '7.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2, 4, 8, 15, 22, 29, 36, 43, and 50', 'description': 'Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'spread': 'NA', 'comment': 'Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate', 'groupId': 'OG000'}, {'value': '160', 'spread': 'NA', 'comment': 'Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate', 'groupId': 'OG001'}, {'value': '362', 'spread': 'NA', 'comment': 'Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate', 'groupId': 'OG002'}, {'value': '330', 'spread': 'NA', 'comment': 'Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2, 4, 8, 15, 22, 29, 36, 43, and 50', 'description': 'Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.', 'unitOfMeasure': 'Day*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'title': 'Day 71', 'categories': [{'measurements': [{'value': '10.4', 'spread': '7.16', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '8.44', 'groupId': 'OG001'}, {'value': '32.8', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '42.1', 'spread': '19.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '18.5', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '28', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '24.4', 'groupId': 'OG002'}, {'value': '60.3', 'spread': '36.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 71 and Day 85', 'description': 'Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.4', 'spread': '29.25', 'groupId': 'OG000', 'lowerLimit': '29.25'}, {'value': '-76.2', 'spread': '25.48', 'groupId': 'OG001', 'lowerLimit': '25.48'}, {'value': '-69.7', 'spread': '24.48', 'groupId': 'OG002', 'lowerLimit': '24.48'}, {'value': '-63.4', 'spread': '25.37', 'groupId': 'OG003', 'lowerLimit': '25.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-47.7', 'spread': '27.27', 'groupId': 'OG000', 'lowerLimit': '27.27'}, {'value': '-57.5', 'spread': '23.1', 'groupId': 'OG001', 'lowerLimit': '23.1'}, {'value': '-43.4', 'spread': '25.38', 'groupId': 'OG002', 'lowerLimit': '25.38'}, {'value': '-46.9', 'spread': '24.31', 'groupId': 'OG003', 'lowerLimit': '24.31'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': 'SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23-31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 \\[absent disease\\] to 103 \\[severe disease\\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.8', 'spread': '68.35', 'groupId': 'OG000', 'lowerLimit': '68.35'}, {'value': '-41.6', 'spread': '35.32', 'groupId': 'OG001', 'lowerLimit': '35.32'}, {'value': '-37.6', 'spread': '34.42', 'groupId': 'OG002', 'lowerLimit': '34.42'}, {'value': '-39.6', 'spread': '40.88', 'groupId': 'OG003', 'lowerLimit': '40.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': "Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '21.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'OG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'OG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-61', 'spread': '31.08', 'groupId': 'OG000', 'lowerLimit': '31.08'}, {'value': '-70', 'spread': '31.93', 'groupId': 'OG001', 'lowerLimit': '31.93'}, {'value': '-60.4', 'spread': '34.04', 'groupId': 'OG002', 'lowerLimit': '34.04'}, {'value': '-50', 'spread': '30.8', 'groupId': 'OG003', 'lowerLimit': '30.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF.', 'unitOfMeasure': 'Percentage of body surface area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Here "Number of participants analyzed" = number of participants who were evaluated for this specific outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'FG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'FG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'FG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 25 sites in 6 countries. A total of 88 participants were screened, and of those, 78 participants were randomized with 77 being treated. Ten participants were screen failures as 5 were due to exclusion criteria met \\& inclusion criteria not met, 4 participants withdrew consent and 1 participant was lost to follow-up.', 'preAssignmentDetails': 'A total of 40 adolescents (aged ≥12 to \\<18 years) and 38 children (aged ≥6 to \\<12 years) were enrolled and randomized to 2 sequential ascending dose cohorts: Cohort 1 (2 mg/kg) and Cohort 2 (4 mg/kg).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dupilumab 2mg/kg: Adolescents', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'BG001', 'title': 'Dupilumab 2mg/kg: Children', 'description': 'Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'BG002', 'title': 'Dupilumab 4mg/kg: Adolescents', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \\<18 years.'}, {'id': 'BG003', 'title': 'Dupilumab 4mg/kg: Children', 'description': 'Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \\<12 years.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.01', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.62', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '1.66', 'groupId': 'BG002'}, {'value': '8.2', 'spread': '1.99', 'groupId': 'BG003'}, {'value': '11.5', 'spread': '3.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4', 'classes': [{'categories': [{'title': 'IGA score of 3', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'IGA score of 4', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF.', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) score', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '17', 'groupId': 'BG000'}, {'value': '32.9', 'spread': '15.53', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '38.8', 'spread': '18.64', 'groupId': 'BG003'}, {'value': '33.7', 'spread': '16.62', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on Safety Analysis set (SAF).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pruritus Numerical Rating Scale (NRS)', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '2.47', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '2.23', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '2.21', 'groupId': 'BG002'}, {'value': '6.7', 'spread': '2.35', 'groupId': 'BG003'}, {'value': '6.5', 'spread': '2.29', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Weekly average obtained in the 7-day period prior to the baseline visit. Analysis was performed on SAF.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area (BSA) Involvement with Atopic Dermatitis (AD)', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '24.78', 'groupId': 'BG000'}, {'value': '59', 'spread': '22.49', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '25.34', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '30.34', 'groupId': 'BG003'}, {'value': '54.6', 'spread': '26.19', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', '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. Analysis was performed on SAF.', 'unitOfMeasure': 'Percentage of body surface area', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SCORing Atopic Dermatitis (SCORAD) Score', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '13.19', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '13.06', 'groupId': 'BG001'}, {'value': '63', 'spread': '14.43', 'groupId': 'BG002'}, {'value': '72.7', 'spread': '12.96', 'groupId': 'BG003'}, {'value': '67.5', 'spread': '13.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23-31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 \\[absent disease\\] to 103 \\[severe disease\\]). Analysis was performed on SAF.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-24', 'studyFirstSubmitDate': '2015-03-31', 'resultsFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-10', 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration', 'timeFrame': 'Day 2, 4, 8, 15, 22, 29, 36, 43, and 50', 'description': 'Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.'}, {'measure': 'PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration', 'timeFrame': 'Day 2, 4, 8, 15, 22, 29, 36, 43, and 50', 'description': 'Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.'}, {'measure': 'PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose', 'timeFrame': 'Pre-dose on Day 71 and Day 85', 'description': 'Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).'}, {'measure': 'Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': 'SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23-31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 \\[absent disease\\] to 103 \\[severe disease\\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.'}, {'measure': 'Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12', 'timeFrame': 'Baseline to Week 12 (one week after last dose)', 'description': "Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF."}, {'measure': 'Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12', 'timeFrame': 'Week 12', 'description': 'IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.'}, {'measure': 'Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eczema'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '35567671', 'type': 'DERIVED', 'citation': "Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14."}, {'pmid': '31595499', 'type': 'DERIVED', 'citation': 'Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, Zhang Y, Zhu X, Chen Z, Li M, Ardeleanu M, Teper A, Akinlade B, Gadkari A, Eckert L, Kamal MA, Ruddy M, Graham NMH, Pirozzi G, Stahl N, DiCioccio AT, Bansal A. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85-96. doi: 10.1111/bjd.18476. Epub 2019 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \\<18 years of age) or severe AD (for children ≥6 to \\<12 years of age).\n\nThe secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \\<18 years of age) or severe AD (for children ≥6 to \\<12 years of age).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female patients ≥6 to \\<18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications\n2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA)\n\n 1. IGA = 3 or 4 in adolescents ≥12 to \\<18 year of age\n 2. IGA = 4 in children ≥6 to \\<12 years of age\n\nKey Exclusion Criteria:\n\n1. Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics\n2. History of any of the following infections:\n\n 1. Any systemic infection requiring treatment within 4 weeks before the baseline visit\n 2. Superficial skin infections within 1 week before the baseline visit\n 3. Known history of HIV infection\n 4. History of seropositivity to hepatitis B or C screening tests\n 5. History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation\n3. History of malignancy within 5 years before the baseline visit\n4. Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase \\[ALT\\] and/or aspartate aminotransferase \\[AST\\]) more than 3 times the upper limit of normal (ULN) during the screening period\n5. Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study\n6. Presence of skin comorbidities that may interfere with study assessments\n7. Females patients who are pregnant or breastfeeding\n8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception"}, 'identificationModule': {'nctId': 'NCT02407756', 'briefTitle': 'A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'R668-AD-1412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1 will receive dupilumab dosing regimen 1', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2 will receive dupilumab dosing regimen 2', 'interventionNames': ['Drug: Dupilumab']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['REGN668(SAR231893)'], 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Kutná Hora', 'country': 'Czechia', 'geoPoint': {'lat': 49.94839, 'lon': 15.26816}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Gera', 'country': 'Germany', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Lübeck', 'country': 'Germany', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Kaposvár', 'country': 'Hungary', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'city': 'Miskolc', 'country': 'Hungary', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szolnok', 'country': 'Hungary', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}