Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-28 @ 2:51 AM
Study NCT ID:
NCT01904604
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2013-07-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '(301) 594-7669', 'title': 'Director, Clinical Research Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For the Placebo Patch group, data were collected for 52 weeks of double-blind dosing with a placebo patch and 130 weeks of open label dosing on active treatment with the DBV712 Viaskin® Patch with 250 µg peanut protein. For the 100 µg Peanut Patch group and the 250 µg Peanut Patch group, data were collected for 52 weeks of double-blind dosing and then 78 weeks of open label dosing for a total of 130 weeks of active treatment.', 'description': "This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Patch Before Week 52 OFC (Double Blind)', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)', 'description': 'After 52 weeks of double-blind Placebo Patch therapy, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1125, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 13802, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 12823, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 16443, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Application site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 329, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5335, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4822, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 5066, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Application site papules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 128, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2918, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2725, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4575, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 728, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 11580, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 9175, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 14214, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Allergy to animal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastoenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 26, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mole excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tonsilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With a Successful Treatment Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '33.8', 'paramValue': '33.8', 'ciLowerLimit': '10.2', 'ciUpperLimit': '57.5', 'pValueComment': 'A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.', 'groupDescription': 'The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.', 'statisticalMethod': "Barnard's statistic", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '36.0', 'paramValue': '36.0', 'ciLowerLimit': '12.6', 'ciUpperLimit': '59.4', 'pValueComment': 'A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.', 'groupDescription': 'The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.', 'statisticalMethod': "Barnard's statistic", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.48', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '2.2', 'paramValue': '2.2', 'ciLowerLimit': '-25.8', 'ciUpperLimit': '30.1', 'pValueComment': 'A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.', 'statisticalMethod': "Barnard's statistic", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Desensitized to Peanut Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '24.9'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '42.2'}, {'value': '36.0', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '57.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 130 (Month 30)', 'description': 'Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:\n\n1\\) 0-44 mg at BL, \\>=444 mg at Wk 130 2) \\>44-\\<444 mg at BL, 10-fold increase at Wk 130 3) \\>=444 mg at BL, \\>=5,044 mg at Wk 130.\n\nBL=Baseline, Wk 130=Week 130 (Month 30)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'title': 'SCD>=1044 mg peanut protein', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '31.7'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '37.4'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '53.5'}]}]}, {'title': 'SCD=5044 mg peanut protein', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '13.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 130 (Month 30)', 'description': 'Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:\n\n0-44 mg at BL, \\>=444 mg at Wk52 2) \\>44-\\<444 mg at BL, 10-fold increase at Wk 52 3) \\>=444 mg at BL, \\>=5,044 mg at Wk 52.\n\nBL=Baseline, Wk 52=Week 52', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received active (not placebo) study treatment.'}, {'type': 'SECONDARY', 'title': 'Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5044'}, {'value': '144', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '2044'}, {'value': '144', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2044'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments were made to the p-value.', 'groupDescription': 'The null hypothesis was that there was no difference between treatment groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The two-sided t approximation was used.'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments were made to the p-value.', 'groupDescription': 'The null hypothesis was that there was no difference between treatment groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The two-sided t approximation was used.'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments were made to the p-value.', 'groupDescription': 'The null hypothesis was that there was no difference between treatment groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The two-sided t approximation was used.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 52', 'description': 'The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.', 'unitOfMeasure': 'mg protein', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who completed the Week 52 OFC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'timeFrame': '8 and 20 weeks after the Week 130 (Month 30) OFC', 'description': 'Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the participants passed the Week 130 OFC so this could not be assessed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'title': 'Had AE related to study therapy through Week 52', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Had AE related to study therapy through Month 30', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and Month 30 (Week 130)', 'description': 'Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received study treatment were included in the analysis. For the Placebo Patch group, at Week 130 only the 20 participants who crossed over to active treatment were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'OG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': '64.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 30 (Week 130)', 'description': 'Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received active (not placebo) study treatment. The Placebo Patch group includes the 20 subjects who crossed over to active treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'FG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'FG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Completed Week 52 OFC', 'comment': 'Completion of the Week 52 OFC was required to assess the primary endpoint of the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Began Crossover Treatment', 'achievements': [{'comment': '2 participants who completed the Week 52 OFC did not crossover; 1 passed the OFC and 1 relocated.', 'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'comment': 'Per protocol, this treatment group did not crossover.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Week 130 OFC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'COMPLETED: Completed the Week 130 Oral Food Challenge (OFC).', 'groupId': 'FG000', 'numSubjects': '18'}, {'comment': 'COMPLETED: Completed the Week 130 Oral Food Challenge (OFC).', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': 'COMPLETED: Completed the Week 130 Oral Food Challenge (OFC).', 'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrew before receiving dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Anxiety about OFC/Refused OFC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patch site reactions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Increased syncope', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unrelated illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Passed Week 52 OFC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment took place from September 2013 to July 2014 at the five listed university-based medical centers located in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nPlacebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'BG001', 'title': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).\n\nLow-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'BG002', 'title': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).\n\nHigh-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '3.4', 'groupId': 'BG002'}, {'value': '9.5', 'spread': '3.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Atopic Dermatitis Total Score', 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '1.6', 'spread': '2.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total IgE', 'classes': [{'categories': [{'measurements': [{'value': '751.8', 'spread': '797.6', 'groupId': 'BG000'}, {'value': '949.1', 'spread': '1183.5', 'groupId': 'BG001'}, {'value': '691.5', 'spread': '602.3', 'groupId': 'BG002'}, {'value': '795.4', 'spread': '884.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Total amount of serum immunoglobulin E.', 'unitOfMeasure': 'kU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peanut IgE', 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '69.4', 'groupId': 'BG000'}, {'value': '87.6', 'spread': '65.3', 'groupId': 'BG001'}, {'value': '89.9', 'spread': '64.3', 'groupId': 'BG002'}, {'value': '84.9', 'spread': '65.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of \\<0.35 kUA/L are considered not to be sensitized to peanut.', 'unitOfMeasure': 'kUA/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Prick Test Score', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '13.3', 'spread': '7.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of \\< 3 mm are considered to have a negative result.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at Initial Peanut Allergic Reaction', 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '2.0', 'groupId': 'BG002'}, {'value': '2.3', 'spread': '2.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized subjects who received study treatment. Note that 1 subject in the 100 µg Peanut Patch group who never received treatment was not included.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-21', 'studyFirstSubmitDate': '2013-07-15', 'resultsFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-15', 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With a Successful Treatment Response', 'timeFrame': 'Week 52', 'description': 'Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Desensitized to Peanut Protein', 'timeFrame': 'Week 130 (Month 30)', 'description': 'Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:\n\n1\\) 0-44 mg at BL, \\>=444 mg at Wk 130 2) \\>44-\\<444 mg at BL, 10-fold increase at Wk 130 3) \\>=444 mg at BL, \\>=5,044 mg at Wk 130.\n\nBL=Baseline, Wk 130=Week 130 (Month 30)'}, {'measure': 'Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein', 'timeFrame': 'Week 130 (Month 30)', 'description': 'Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein.'}, {'measure': 'Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)', 'timeFrame': 'Week 52', 'description': 'Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:\n\n0-44 mg at BL, \\>=444 mg at Wk52 2) \\>44-\\<444 mg at BL, 10-fold increase at Wk 52 3) \\>=444 mg at BL, \\>=5,044 mg at Wk 52.\n\nBL=Baseline, Wk 52=Week 52'}, {'measure': 'Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)', 'timeFrame': 'Week 52', 'description': 'The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.'}, {'measure': 'Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)', 'timeFrame': '8 and 20 weeks after the Week 130 (Month 30) OFC', 'description': 'Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.'}, {'measure': 'Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months', 'timeFrame': 'Week 52 and Month 30 (Week 130)', 'description': 'Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.'}, {'measure': 'Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy', 'timeFrame': 'Month 30 (Week 130)', 'description': 'Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peanut Allergy', 'Food Allergy', 'Viaskin peanut patch', 'Allergen Immunotherapy', 'Epicutaneous Immunotherapy', 'Whole peanut extract', 'Allergenic product', 'Immediate hypersensitivity'], 'conditions': ['Peanut Hypersensitivity', 'Food Hypersensitivity', 'Hypersensitivity', 'Hypersensitivity, Immediate']}, 'referencesModule': {'references': [{'pmid': '24789880', 'type': 'BACKGROUND', 'citation': 'Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1.'}, {'pmid': '28091362', 'type': 'RESULT', 'citation': 'Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26.'}, {'pmid': '33290772', 'type': 'DERIVED', 'citation': 'Scurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5.'}, {'pmid': '29408715', 'type': 'DERIVED', 'citation': 'Chiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID) Website'}, {'url': 'http://www.cofargroup.org/', 'label': 'Consortium of Food Allergy Research (CoFAR) Website'}]}, 'descriptionModule': {'briefSummary': 'Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.', 'detailedDescription': 'This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed peanut allergy OR convincing history of peanut allergy\n* A skin prick test positive to peanut (wheal diameter ≥3mm greater than the saline control) OR detectable peanut specific Immunoglobulin E (IgE) (ImmunoCAP \\>0.35 kUA/L)\n* Positive reaction to a cumulative dose of ≤1044 mg peanut protein in the initial qualifying Oral Food Challenge (OFC)\n* Use of an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study\n* Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994). Children ages 4-11 years who have documented inability to adequately perform spirometry may be enrolled if Peak Expiratory Flow (PEF) is \\>80% of predicted\n* Provide signed informed consent or assent where indicated\n\nExclusion Criteria:\n\n* History of anaphylaxis to peanut resulting in hypotension, neurological compromise or requiring mechanical ventilation\n* Participation in a study using an investigational new drug in the last 30 days\n* Participation in any interventional study for the treatment of food allergy in the past 6 months\n* Pregnancy or lactation\n* Current or known allergy to the Viaskin Peanut/Placebo patch device or excipients\n* Current or known allergy to the placebo allergen (oat flour) in oral food challenge (OFC)\n* Currently in a build-up phase of any allergen immunotherapy\n* Severe or poorly controlled atopic dermatitis or greater than a mild flare of active disease at enrollment\n* Forced Expiratory Volume in 1 Second (FEV1) value \\<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (\\>500mcg of Fluticasone or equivalent)\n* Use of steroid medications in the following manners: history of daily oral steroid dosing for \\>1 month during the past year, or burst or steroid course in the past 3 months, or \\>1 burst oral steroid course in the past year or use of oral or parenteral steroids for a non-asthma indication within the past 30 days\n* Asthma requiring \\>1 hospitalization in the past year for asthma or \\>1 Emergency Department (ED) visit in the past 6 months for asthma\n* Any previous intubation/mechanical ventilation due to allergies or asthma\n* Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory or biologic therapy in the past year\n* Use of beta-adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers in the past 30 days\n* Inability to discontinue antihistamines for skin testing and OFC\n* History of alcohol or drug abuse\n* History of cardiovascular disease, uncontrolled hypertension, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or other medical conditions including immunologic disorders or HIV infection which, in the opinion of the investigator, make the subject unsuitable for treatment or at increased risk of anaphylaxis or poor outcome'}, 'identificationModule': {'nctId': 'NCT01904604', 'briefTitle': 'Peanut Epicutaneous Phase II Immunotherapy Clinical Trial', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)', 'orgStudyIdInfo': {'id': 'DAIT CoFAR6'}, 'secondaryIdInfos': [{'id': '5U19AI066738-07', 'link': 'https://reporter.nih.gov/quickSearch/5U19AI066738-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Patch', 'description': 'Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).', 'interventionNames': ['Biological: Placebo Viaskin® Patch']}, {'type': 'EXPERIMENTAL', 'label': '100 µg Peanut Patch', 'description': 'Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-\\<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).', 'interventionNames': ['Biological: Low-dose DBV712 Viaskin® Patch']}, {'type': 'EXPERIMENTAL', 'label': '250 µg Peanut Patch', 'description': 'Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).', 'interventionNames': ['Biological: High-dose DBV712 Viaskin® Patch']}], 'interventions': [{'name': 'Placebo Viaskin® Patch', 'type': 'BIOLOGICAL', 'description': 'Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.', 'armGroupLabels': ['Placebo Patch']}, {'name': 'Low-dose DBV712 Viaskin® Patch', 'type': 'BIOLOGICAL', 'description': '100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.', 'armGroupLabels': ['100 µg Peanut Patch']}, {'name': 'High-dose DBV712 Viaskin® Patch', 'type': 'BIOLOGICAL', 'description': '250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.', 'armGroupLabels': ['250 µg Peanut Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Stacie M. Jones, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'url': 'https://immport.niaid.nih.gov/', 'timeFrame': 'After completion of the trial.', 'ipdSharing': 'YES', 'description': 'The plan is to share data in ImmPort \\[https://immport.niaid.nih.gov/ \\], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.', 'accessCriteria': 'After completion of the trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Consortium of Food Allergy Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}