Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03736967
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720033', 'term': 'itepekimab'}, {'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Participants discontinued study drug and transitioned into the post-treatment follow-up period. As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.'}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 17, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'R3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 15, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 25, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'R3500 300 mg and Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 20, 'seriousNumAtRisk': 52, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': "Goodpasture's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Ruptured cerebral aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.4', 'spread': '31.86', 'groupId': 'OG000'}, {'value': '-66.6', 'spread': '22.46', 'groupId': 'OG001'}, {'value': '-77.8', 'spread': '23.73', 'groupId': 'OG002'}, {'value': '-76.9', 'spread': '20.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.', 'unitOfMeasure': 'Percentage of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.6', 'spread': '36.58', 'groupId': 'OG000'}, {'value': '-58.0', 'spread': '29.69', 'groupId': 'OG001'}, {'value': '-77.4', 'spread': '22.59', 'groupId': 'OG002'}, {'value': '-75.8', 'spread': '19.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.', 'unitOfMeasure': 'Percentage of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}, {'value': '95.5', 'groupId': 'OG002'}, {'value': '85.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}, {'value': '96.2', 'groupId': 'OG002'}, {'value': '87.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}, {'value': '63.6', 'groupId': 'OG002'}, {'value': '60.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. Percentage of participants who achieved EASI-75 (\\>= 75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}, {'value': '58.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '40.9', 'groupId': 'OG002'}, {'value': '35.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}, {'value': '29.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.25', 'spread': '8.073', 'groupId': 'OG000'}, {'value': '-18.94', 'spread': '9.383', 'groupId': 'OG001'}, {'value': '-25.40', 'spread': '15.769', 'groupId': 'OG002'}, {'value': '-23.28', 'spread': '9.177', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 was reported.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.18', 'spread': '9.819', 'groupId': 'OG000'}, {'value': '-16.46', 'spread': '10.002', 'groupId': 'OG001'}, {'value': '-24.06', 'spread': '14.825', 'groupId': 'OG002'}, {'value': '-21.82', 'spread': '9.008', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}, {'value': '35.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of \\>= 2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}, {'value': '29.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.08', 'spread': '2.825', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '1.781', 'groupId': 'OG001'}, {'value': '-3.16', 'spread': '2.607', 'groupId': 'OG002'}, {'value': '-3.92', 'spread': '2.433', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.11', 'spread': '2.651', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '1.743', 'groupId': 'OG001'}, {'value': '-3.19', 'spread': '2.532', 'groupId': 'OG002'}, {'value': '-3.64', 'spread': '2.326', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.6', 'spread': '36.71', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': '22.94', 'groupId': 'OG001'}, {'value': '-44.9', 'spread': '35.73', 'groupId': 'OG002'}, {'value': '-60.2', 'spread': '34.87', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.", 'unitOfMeasure': 'Percentage of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.6', 'spread': '35.04', 'groupId': 'OG000'}, {'value': '-37.8', 'spread': '21.88', 'groupId': 'OG001'}, {'value': '-45.1', 'spread': '34.68', 'groupId': 'OG002'}, {'value': '-55.7', 'spread': '34.22', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.", 'unitOfMeasure': 'Percentage of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS at Week 16 were counted as non-responders.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '41.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.\n\nDue to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'timeFrame': 'Week 16', 'description': 'Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being \'no itch\' and 10 being the \'worst itch imaginable,\' how would you rate your itch at the worst moment during the previous 24 hours?"\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'timeFrame': 'Week 16', 'description': 'The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'timeFrame': 'Week 16', 'description': 'BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children).\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Participants with AESIs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 16', 'description': 'Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF) included all randomized participants who received any study drug and was based on the treatment received (as treated).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Participants with AESIs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 36', 'description': 'AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant ALT elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all randomized participants who received any study drug and was based on the treatment received (as treated).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 36', 'description': 'Treatment-Emergent (TE) ADA: any positive post baseline assay response when baseline results were negative/missing. TE ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \\[based on nominal sampling time\\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Here, "Number of Participants Analysed" signifies those participants who were evaluable for this endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA analysis set (AAS) included all participants who received any study drug and had at least 1 non-missing ADA result in the respective ADA assays, after the first dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Functional REGN3500', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.00373', 'spread': '0.0269', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '9.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.6', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.8', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '63.0', 'spread': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.4', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.31', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '2.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36', 'description': 'Serum Concentration of Functional REGN3500 was reported. Data was reported for REGN3500 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only', 'unitOfMeasure': 'Milligrams per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug (active or placebo \\[safety analysis set\\]) and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable at given time points.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Functional Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'OG001', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.00219', 'spread': '0.0158', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.5', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.0', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.4', 'spread': '37.8', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '39.2', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '30.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.8', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '24.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.36', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0227', 'spread': '0.0850', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36', 'description': 'Serum Concentration of Functional Dupilumab was reported.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were reported for Dupilumab 300 gm Q2W and REGN3500 300 mg + Dupilumab 200 mg Q2W arms only. Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug (active or placebo \\[safety analysis set\\]) and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable at given time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'FG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'FG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'FG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Randomized but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 299 participants were screened at sites in Republic of Korea, United States of America, Germany, Poland, Czech Republic, Belgium and Spain. Out of 299 participants, 206 participants met eligibility criteria and randomized in this study.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1:1 ratio to 1 of the 4 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 300 milligrams (mg) Q2W; Dupilumab 300 mg Q2W and combination of REGN3500 300 mg and Dupilumab 300 mg Q2W.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Q2W', 'description': 'Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'BG001', 'title': 'REGN3500 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.'}, {'id': 'BG002', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.'}, {'id': 'BG003', 'title': 'REGN3500 300 mg + Dupilumab 300 mg Q2W', 'description': 'Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '14.04', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '12.19', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '15.89', 'groupId': 'BG002'}, {'value': '32.1', 'spread': '12.10', 'groupId': 'BG003'}, {'value': '34.7', 'spread': '13.74', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '28.2', 'spread': '9.54', 'groupId': 'BG000'}, {'value': '29.9', 'spread': '13.02', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '13.86', 'groupId': 'BG002'}, {'value': '29.0', 'spread': '10.74', 'groupId': 'BG003'}, {'value': '29.4', 'spread': '11.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS includes all randomized participants and was based on the treatment allocated (as randomized). Here, "Number of Participants Analyzed" signifies those participants who were evaluable at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-17', 'size': 898096, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-01T11:41', 'hasProtocol': True}, {'date': '2020-06-17', 'size': 672562, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-01T11:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2021-03-12', 'completionDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2018-11-07', 'dispFirstSubmitQcDate': '2021-03-18', 'resultsFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2018-11-07', 'dispFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-01', 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. Percentage of participants who achieved EASI-75 (\\>= 75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.'}, {'measure': 'Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.'}, {'measure': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 was reported.'}, {'measure': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.'}, {'measure': 'Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of \\>= 2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders.'}, {'measure': 'Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': 'IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.'}, {'measure': 'Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported."}, {'measure': 'Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported."}, {'measure': 'Percent Change From Baseline in in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders."}, {'measure': 'Percent Change From Baseline in in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported."}, {'measure': 'Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS at Week 16 were counted as non-responders."}, {'measure': 'Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on all observed values regardless of rescue treatment were reported."}, {'measure': 'Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)', 'timeFrame': 'Week 16', 'description': 'Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being \'no itch\' and 10 being the \'worst itch imaginable,\' how would you rate your itch at the worst moment during the previous 24 hours?"\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.'}, {'measure': 'Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16', 'timeFrame': 'Week 16', 'description': 'The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.'}, {'measure': 'Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16', 'timeFrame': 'Week 16', 'description': 'BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children).\n\nDue to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant ALT elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.'}, {'measure': 'Number of Participants With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab', 'timeFrame': 'Baseline up to Week 36', 'description': 'Treatment-Emergent (TE) ADA: any positive post baseline assay response when baseline results were negative/missing. TE ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \\[based on nominal sampling time\\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Here, "Number of Participants Analysed" signifies those participants who were evaluable for this endpoint.'}, {'measure': 'Serum Concentration of Functional REGN3500', 'timeFrame': 'Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36', 'description': 'Serum Concentration of Functional REGN3500 was reported. Data was reported for REGN3500 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only'}, {'measure': 'Serum Concentration of Functional Dupilumab', 'timeFrame': 'Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36', 'description': 'Serum Concentration of Functional Dupilumab was reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate', 'Severe'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD).\n\nSecondary Objectives are to:\n\n* Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD\n* Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD\n* Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit\n2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits\n3. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits\n4. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable\n\nKey Exclusion Criteria:\n\n1. Prior participation in an anti-Interleukin (IL)-33 class antibody (including but not limited to REGN3500) or anti-IL-4Rα class antibody (including but not limited to dupilumab) clinical study; past treatment with or current treatment with dupilumab or another anti-IL-4Rα treatment\n2. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit\n3. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment\n4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening\n5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit\n6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study\n\nNote: Other protocol defined Inclusion/Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT03736967', 'briefTitle': 'Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'R3500-AD-1798'}, 'secondaryIdInfos': [{'id': '2018-001543-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REGN3500', 'interventionNames': ['Drug: REGN3500']}, {'type': 'EXPERIMENTAL', 'label': 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