Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04394351
Status:
COMPLETED
Last Update Posted:
2025-10-27
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of the informed consent up to week 152.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Pooled Placebo (Placebo)', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 28, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 24, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 26, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part B: Placebo to Dupilumab Low Dos', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 27, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 31, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 48, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 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'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Obstructive sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Oesophageal food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Endoscopy gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of Less Than or Equal to (≤) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '15.33'}, {'value': '67.6', 'groupId': 'OG001', 'lowerLimit': '50.21', 'upperLimit': '81.99'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '39.08', 'upperLimit': '75.45'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.8', 'ciLowerLimit': '7.37', 'ciUpperLimit': '392.82', 'estimateComment': 'Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.7', 'ciLowerLimit': '5.47', 'ciUpperLimit': '399.54', 'estimateComment': 'Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-value was derived by CMH test stratified by baseline weight group.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '15.33'}, {'value': '83.8', 'groupId': 'OG001', 'lowerLimit': '67.99', 'upperLimit': '93.81'}, {'value': '67.7', 'groupId': 'OG002', 'lowerLimit': '48.63', 'upperLimit': '83.32'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '178.0', 'ciLowerLimit': '18.84', 'ciUpperLimit': '1682.4', 'estimateComment': 'Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-value was derived by CMH test stratified by baseline weight group'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.3', 'ciLowerLimit': '7.45', 'ciUpperLimit': '410.23', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-value was derived by CMH test stratified by baseline weight group'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.98', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '-86.09', 'spread': '11.84', 'groupId': 'OG001'}, {'value': '-77.93', 'spread': '12.89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-107.07', 'ciLowerLimit': '-139.249', 'ciUpperLimit': '-74.900', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-98.92', 'ciLowerLimit': '-132.463', 'ciUpperLimit': '-65.370', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available. Least squared (LS) mean and standard error (SE) from analysis of covariance (ANCOVA) model with Baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.023', 'spread': '0.0498', 'groupId': 'OG000'}, {'value': '-0.879', 'spread': '0.0481', 'groupId': 'OG001'}, {'value': '-0.757', 'spread': '0.0524', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.902', 'ciLowerLimit': '-1.0325', 'ciUpperLimit': '-0.7714', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.780', 'ciLowerLimit': '-0.9170', 'ciUpperLimit': '-0.6440', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean grade scores summed over the 3 regions was the final score used in primary analysis, the mean grade score ranged from 0 to 3, with higher score indicating more severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.048', 'spread': '0.0482', 'groupId': 'OG000'}, {'value': '-0.835', 'spread': '0.0466', 'groupId': 'OG001'}, {'value': '-0.721', 'spread': '0.0507', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.883', 'ciLowerLimit': '-1.0095', 'ciUpperLimit': '-0.7568', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.769', 'ciLowerLimit': '-0.9013', 'ciUpperLimit': '-0.6362', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '-1.84', 'upperLimit': '1.65'}, {'value': '-1.895', 'groupId': 'OG001', 'lowerLimit': '-2.03', 'upperLimit': '-1.61'}, {'value': '-1.930', 'groupId': 'OG002', 'lowerLimit': '-2.00', 'upperLimit': '-1.39'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.220', 'ciLowerLimit': '-2.4400', 'ciUpperLimit': '-1.9500', 'estimateComment': 'Median Difference is Dupilumab minus Placebo', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.190', 'ciLowerLimit': '-2.4500', 'ciUpperLimit': '-1.8200', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'Median Difference is Dupilumab minus Placebo', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at Week 16 relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have a minimum/maximum score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Eosinophilic Esophagitis (EoE) Diagnostic Panel (EDP) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.180', 'groupId': 'OG000', 'lowerLimit': '-2.53', 'upperLimit': '2.39'}, {'value': '-2.630', 'groupId': 'OG001', 'lowerLimit': '-2.85', 'upperLimit': '-2.25'}, {'value': '-2.710', 'groupId': 'OG002', 'lowerLimit': '-2.84', 'upperLimit': '-0.80'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.840', 'ciLowerLimit': '-3.3500', 'ciUpperLimit': '-1.9600', 'estimateComment': 'Median Difference is Dupilumab minus Placebo', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.700', 'ciLowerLimit': '-3.3100', 'ciUpperLimit': '-1.6200', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'Median Difference is Dupilumab minus Placebo', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at Week 16 relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-4.94', 'ciUpperLimit': '-2.63', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-4.59', 'ciUpperLimit': '-2.10', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs as Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 16 (for Participants Aged ≥1 to <12 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.060', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.244', 'ciUpperLimit': '0.038', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9533', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.155', 'ciUpperLimit': '0.146', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Sign-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.93', 'spread': '0.756', 'groupId': 'OG000'}, {'value': '10.38', 'spread': '0.735', 'groupId': 'OG001'}, {'value': '8.93', 'spread': '0.840', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1507', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '-0.527', 'ciUpperLimit': '3.422', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9965', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-2.107', 'ciUpperLimit': '2.117', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS mean SE derived from ANCOVA model.', 'unitOfMeasure': 'sign-free days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.036', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.139', 'ciUpperLimit': '0.030', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6361', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.112', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of segments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.067', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.330', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2975', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.088', 'ciUpperLimit': '0.286', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measured occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Number of Symptom-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.49', 'spread': '0.953', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '1.081', 'groupId': 'OG001'}, {'value': '9.13', 'spread': '0.936', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-4.615', 'ciUpperLimit': '1.007', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3098', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-3.972', 'ciUpperLimit': '1.260', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. The PESQ-P score was calculated based on the daily responses over a 14-day period (i.e., the 14 days prior to the baseline visit and the week 16 visit). The score ranges from 0 to 1. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS Mean SE from ANCOVA.', 'unitOfMeasure': 'sign-free days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.039', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.046', 'ciUpperLimit': '0.186', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab High Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1939', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.037', 'ciUpperLimit': '0.181', 'pValueComment': 'P-value is not adjusted for multiple comparisons', 'estimateComment': 'CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.', 'groupDescription': 'Part A: Dupilumab Low Dose versus Part A: Pooled Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of segments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Total Score as Measured by the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) Version 2.0 Caregiver Version (PEESSv2.0-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.83', 'spread': '2.909', 'groupId': 'OG000'}, {'value': '-19.86', 'spread': '2.577', 'groupId': 'OG001'}, {'value': '-10.10', 'spread': '2.785', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The PEESSv2.0-C is a caregiver-reported outcome measure that assesses the frequency and severity of EoE symptoms among pediatric participants. The PEESSv2.0-C consists of 20 items and has a one-month recall period. Each item had a 0-4 scale, which was transformed to 0-100 as follows: 0 = 0, 1 = 25, 2 = 50, 3 = 75, 4 = 100. The mean total PEESSv2.0 score was computed as the sum of all the item scores over the number of items answered. The total PEESSv2.0-C score ranges from 0 to 100 where higher scores indicate greater symptom burden among pediatric EoE participants. Values after first rescue treatment use were set to missing (censoring). WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the MI approach was used for the missing data due to other reasons. LS mean SE from ANCOVA model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A FAS which included all randomized participants in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Concentration of Functional Dupilumab in Serum at Baseline, Week 4 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG001', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.7', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163', 'spread': '60.8', 'groupId': 'OG000'}, {'value': '86.0', 'spread': '29.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and 16', 'description': 'Concentration of functional dupilumab in serum at Baseline, Week 4 and 16 was reported in this outcome measure.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on pharmacokinetic analysis set (PKAS) that includes all participants who received any study drug and had at least 1 non-missing result following the first dose of study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils/High Power Field at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '52.9', 'groupId': 'OG001'}, {'value': '65.5', 'groupId': 'OG002'}, {'value': '62.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B safety analysis set (SAF) which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}, {'value': '69.0', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.72', 'spread': '19.229', 'groupId': 'OG000'}, {'value': '-76.83', 'spread': '41.228', 'groupId': 'OG001'}, {'value': '-85.41', 'spread': '22.851', 'groupId': 'OG002'}, {'value': '-90.97', 'spread': '14.482', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.804', 'spread': '0.3099', 'groupId': 'OG000'}, {'value': '-0.885', 'spread': '0.2962', 'groupId': 'OG001'}, {'value': '-0.773', 'spread': '0.3374', 'groupId': 'OG002'}, {'value': '-0.967', 'spread': '0.3920', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean grade scores summed over the 3 regions was the final score used in primary analysis, the mean grade score ranged from 0 to 3, with higher score indicating more severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.767', 'spread': '0.3114', 'groupId': 'OG000'}, {'value': '-0.855', 'spread': '0.3485', 'groupId': 'OG001'}, {'value': '-0.784', 'spread': '0.3183', 'groupId': 'OG002'}, {'value': '-0.892', 'spread': '0.3181', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.82', 'spread': '1.722', 'groupId': 'OG000'}, {'value': '-3.64', 'spread': '3.342', 'groupId': 'OG001'}, {'value': '-4.50', 'spread': '3.203', 'groupId': 'OG002'}, {'value': '-4.77', 'spread': '3.081', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores possibly ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.373', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.395', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.339', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.299', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Sign-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.58', 'spread': '3.968', 'groupId': 'OG000'}, {'value': '12.10', 'spread': '4.652', 'groupId': 'OG001'}, {'value': '11.35', 'spread': '3.947', 'groupId': 'OG002'}, {'value': '12.13', 'spread': '4.053', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.', 'unitOfMeasure': 'sign-free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.249', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.221', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.250', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '0.187', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measured the occurrence of signs of EoE and was completed once daily via an electronic diary.', 'unitOfMeasure': 'proportion of segments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.322', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.369', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.400', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.396', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measured occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Symptom-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.33', 'spread': '8.083', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '5.715', 'groupId': 'OG001'}, {'value': '10.64', 'spread': '4.943', 'groupId': 'OG002'}, {'value': '13.63', 'spread': '0.874', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food.', 'unitOfMeasure': 'sign-free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.269', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.293', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.284', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.', 'unitOfMeasure': 'proportion of segments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.715', 'groupId': 'OG000', 'lowerLimit': '-2.755', 'upperLimit': '-2.505'}, {'value': '-2.615', 'groupId': 'OG001', 'lowerLimit': '-2.810', 'upperLimit': '-2.430'}, {'value': '-2.625', 'groupId': 'OG002', 'lowerLimit': '-2.775', 'upperLimit': '-2.550'}, {'value': '-2.670', 'groupId': 'OG003', 'lowerLimit': '-2.710', 'upperLimit': '-2.530'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 52', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.960', 'groupId': 'OG000', 'lowerLimit': '-2.000', 'upperLimit': '-1.895'}, {'value': '-1.965', 'groupId': 'OG001', 'lowerLimit': '-1.995', 'upperLimit': '-1.765'}, {'value': '-1.920', 'groupId': 'OG002', 'lowerLimit': '-1.965', 'upperLimit': '-1.865'}, {'value': '-1.920', 'groupId': 'OG003', 'lowerLimit': '-1.930', 'upperLimit': '-1.850'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 52', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at post-baseline relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Body Weight for Age Percentile at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '13.893', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '12.644', 'groupId': 'OG001'}, {'value': '4.75', 'spread': '11.968', 'groupId': 'OG002'}, {'value': '5.96', 'spread': '11.519', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Body weight for age percentile was calculated based on the growth charts from the Centers for Disease Control and Prevention (CDC) for ages 0 to 20 years (for ages 2 to \\<12 years) and World Health Organization (WHO) growth charts for ages 0 to \\<2 years (for ages 1 to \\<2 years). These charts included a set of smoothed percentiles along with CDC LMS (Lambda-Mu-Sigma) parameters to allow the calculation of percentiles.', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Body Mass Index (BMI) for Age Z-score for Participants ≥2 Years of Age at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0206', 'spread': '0.54625', 'groupId': 'OG000'}, {'value': '0.0687', 'spread': '0.47605', 'groupId': 'OG001'}, {'value': '-0.0549', 'spread': '0.88582', 'groupId': 'OG002'}, {'value': '0.0987', 'spread': '0.72329', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'BMI for age z-score indicates how much higher or lower a participant\'s BMI for age is relative to a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in BMI for age z-score (ie, increase in the standard deviation \\[SD\\] from the reference growth chart) indicates an increase in BMI for age relative to the reference.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Weight for Age Z-score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0640', 'spread': '0.46264', 'groupId': 'OG000'}, {'value': '0.2016', 'spread': '0.39446', 'groupId': 'OG001'}, {'value': '0.1445', 'spread': '0.40310', 'groupId': 'OG002'}, {'value': '0.2049', 'spread': '0.40305', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Weight for age z-score indicates how much higher or lower a participant\'s weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and World Health Organization (WHO) growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Body Weight From Height Z-score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0962', 'spread': '0.48902', 'groupId': 'OG000'}, {'value': '-0.0100', 'spread': '0.51706', 'groupId': 'OG001'}, {'value': '-0.2700', 'spread': '1.04895', 'groupId': 'OG002'}, {'value': '-0.0151', 'spread': '0.67968', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Weight for height z-score indicates how much higher or lower a participant\'s weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and WHO growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Concentration of Functional Dupilumab in Serum at Week 32 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '105', 'spread': '49.8', 'groupId': 'OG000'}, {'value': '142', 'spread': '48.5', 'groupId': 'OG001'}, {'value': '99.0', 'spread': '42.8', 'groupId': 'OG002'}, {'value': '186', 'spread': '59.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '44.3', 'groupId': 'OG000'}, {'value': '149', 'spread': '59.1', 'groupId': 'OG001'}, {'value': '83.0', 'spread': '33.2', 'groupId': 'OG002'}, {'value': '179', 'spread': '75.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 32 and 52', 'description': 'Concentration of functional dupilumab in serum at Week 32 and 52 was reported in this outcome measure.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PKAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'title': 'Participants with any TEAE', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any AESI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any TEAE leading to permanent discontinuation of study drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': "An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part A SAF which included all randomized patients who received any Part A study drug.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'title': 'Participants with any TEAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any TEAE leading to permanent discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 16 up to Week 52 in Part B', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on ADA analysis set (AAS) which included all participants who received any amount of study drug (active or placebo) and had at least one non-missing anti-drug antibody result following the first dose of study drug or placebo. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) by Maximum Titer Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'OG001', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}], 'classes': [{'title': 'Treatment-emergent ADA Titer: Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-emergent ADA Titer: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-emergent ADA Titer: High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on AAS which included all participants who received any amount of study drug (active or placebo) and had at least one non-missing anti-drug antibody result following the first dose of study drug or placebo. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and overall number of participants analyzed = 0 denotes that no participant had positive treatment-emergent ADA response to measure titer level."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response and Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG001', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'OG002', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'OG003', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 16 up to Week 52 in Part B', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.\n\nNo participant exhibited a treatment-emergent ADA response in Part B and titer was not reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on AAS which included all participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose.'}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf At Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 100', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf At Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'At Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) From Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-91.50', 'spread': '13.348', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 100', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) From Baseline to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline to Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'title': 'EoE-HSS Grade Score', 'categories': [{'measurements': [{'value': '-0.851', 'spread': '0.3909', 'groupId': 'OG000'}]}]}, {'title': 'EoE-HSS Stage Score', 'categories': [{'measurements': [{'value': '-0.850', 'spread': '0.3648', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 100', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline to Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Absolute Change in EoE-EREFS From Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.34', 'spread': '2.535', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 100', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Absolute Change in EoE-EREFS From Baseline to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline to Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Change in Total Score as Measured by the PEESSv2.0- Caregiver Version Questionnaire From Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.03', 'spread': '21.867', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 100', 'description': 'The PEESSv2.0-C is a caregiver-reported outcome measure that assesses the frequency and severity of EoE symptoms among pediatric participants. The PEESSv2.0-C consists of 20 items and has a one-month recall period. Each item had a 0-4 scale, which was transformed to 0-100 as follows: 0 = 0, 1 = 25, 2 = 50, 3 = 75, 4 = 100. The mean total PEESSv2.0 score was computed as the sum of all the item scores over the number of items answered. The total PEESSv2.0-C score ranges from 0 to 100 where higher scores indicate greater symptom burden among pediatric EoE participants.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: NES for the Relative Change in the EDP Transcriptome Signature From Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.720', 'groupId': 'OG000', 'lowerLimit': '-2.800', 'upperLimit': '-2.510'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 100', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: NES for the Relative Change in the EDP Transcriptome Signature From Baseline to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline to Week 160', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: NES for the Relative Change in the Type 2 Inflammation Transcriptome Signature Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.970', 'groupId': 'OG000', 'lowerLimit': '-2.000', 'upperLimit': '-1.900'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 100', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: NES for the Relative Change in the Type 2 Inflammation Transcriptome Signature From Baseline to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline to Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Change in Body Weight for Age Percentile From Baseline up to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '10.63', 'spread': '18.227', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 100', 'description': 'Body weight for age percentile was calculated based on the growth charts from the Centers for Disease Control and Prevention (CDC) for ages 0 to 20 years (for ages 2 to \\<12 years) and World Health Organization (WHO) growth charts for ages 0 to \\<2 years (for ages 1 to \\<2 years). These charts included a set of smoothed percentiles along with CDC LMS (Lambda-Mu-Sigma) parameters to allow the calculation of percentiles.', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Change in Body Mass Index for Age Z-score From Baseline up to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2009', 'spread': '0.67389', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Change in Weight for Age Z-score From Baseline up to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3376', 'spread': '0.59272', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint."}, {'type': 'SECONDARY', 'title': 'Part C: Change in Weight for Age Z-score From Baseline up to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline up to Week 160', 'description': "Weight for age z-score indicates how much higher or lower a participant's weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and World Health Organization (WHO) growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Change in Weight for Height Z-score From Baseline up to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3301', 'spread': '0.84791', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in Weight for height Z-score. Weight for height Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Change in Weight for Height Z-score From Baseline up to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline up to Week 160', 'description': "Weight for height z-score indicates how much higher or lower a participant's weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and WHO growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eos/Hpf (400×) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 100', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Here 'n' = number of evaluable participants at the specified timepoint"}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eos/Hpf (400×) at Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'At Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants (With Food Elimination Diet Regimens at Baseline) That Have a Re-introduction of a Previously Eliminated Food Group From Baseline up to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 100', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants (With Food Elimination Diet Regimens at Baseline) That Have a Re-introduction of a Previously Eliminated Food Group From Baseline up to Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'timeFrame': 'Baseline up to Week 160', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).'}, {'type': 'SECONDARY', 'title': 'Part C: Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 152', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed 160 weeks, longest duration was 152 weeks.'}, {'type': 'SECONDARY', 'title': 'Part C: Number of Participants With Treatment-emergent SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 152', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed 160 weeks, longest duration was 152 weeks.'}, {'type': 'SECONDARY', 'title': 'Part C: Number of Participants With Treatment-emergent AESIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 152', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed 160 weeks, longest duration was 152 weeks.'}, {'type': 'SECONDARY', 'title': 'Part C: Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 152', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed 160 weeks, longest duration was 152 weeks.'}, {'type': 'SECONDARY', 'title': 'Part C: Number of Participants With Treatment-emergent ADA Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 52 up to Week 152', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-Drug Antibody Analysis Set (AAS): The Part C AAS included all participants who received any amount of study drug in Part C and had at least 1 non-missing ADA result following the first dose of study drug. Analysis was based on treatment received.'}, {'type': 'SECONDARY', 'title': 'Part C: Concentration of Functional Dupilumab in Serum at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'spread': '96.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 100', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Pooled Placebo (Placebo)', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'FG001', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W'}, {'id': 'FG002', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'FG003', 'title': 'Part B: Placebo to Dupilumab Low Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W'}, {'id': 'FG004', 'title': 'Part B: Placebo to Dupilumab High Dose', 'description': 'Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'FG005', 'title': 'Part B: Dupilumab Low Dose to Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)'}, {'id': 'FG006', 'title': 'Part B: Dupilumab High Dose to Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'FG007', 'title': 'Part C: Dupilumab', 'description': 'Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment'}], 'periods': [{'title': 'Part A (16 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Part B (36 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '29'}, {'groupId': 'FG006', 'numSubjects': '37'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '29'}, {'groupId': 'FG006', 'numSubjects': '36'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Part C: (Up to Wk108+12Wk Follow-up)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '32'}]}]}], 'preAssignmentDetails': 'This study consisted of 3 parts: Part A (double-blind 16-week treatment period), Part B (36-week extended active treatment period) and Part C (open-label extension period of up to 108 weeks).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Pooled Placebo', 'description': 'Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.'}, {'id': 'BG001', 'title': 'Part A: Dupilumab Low Dose', 'description': 'Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W'}, {'id': 'BG002', 'title': 'Part A: Dupilumab High Dose', 'description': 'Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.03', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '3.07', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '3.11', 'groupId': 'BG002'}, {'value': '7.1', 'spread': '3.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on Part A full analysis set (FAS) which included all randomized participants in Part A.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-03', 'size': 1280697, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-23T15:57', 'hasProtocol': True}, {'date': '2022-06-03', 'size': 4085569, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-13T14:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2023-06-01', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2020-05-07', 'resultsFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2020-05-17', 'dispFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-08-23', 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of Less Than or Equal to (≤) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16', 'timeFrame': 'At Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.'}], 'secondaryOutcomes': [{'measure': 'Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 16', 'timeFrame': 'At Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.'}, {'measure': 'Part A: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available. Least squared (LS) mean and standard error (SE) from analysis of covariance (ANCOVA) model with Baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.'}, {'measure': 'Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean grade scores summed over the 3 regions was the final score used in primary analysis, the mean grade score ranged from 0 to 3, with higher score indicating more severe.'}, {'measure': 'Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.'}, {'measure': 'Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at Week 16 relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have a minimum/maximum score.'}, {'measure': 'Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Eosinophilic Esophagitis (EoE) Diagnostic Panel (EDP) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at Week 16 relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.'}, {'measure': 'Part A: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.'}, {'measure': 'Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs as Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 16 (for Participants Aged ≥1 to <12 Years)', 'timeFrame': 'Baseline, Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.'}, {'measure': 'Part A: Number of Sign-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)', 'timeFrame': 'Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS mean SE derived from ANCOVA model.'}, {'measure': 'Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.'}, {'measure': 'Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measured occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.'}, {'measure': 'Part A: Number of Symptom-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)', 'timeFrame': 'Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. The PESQ-P score was calculated based on the daily responses over a 14-day period (i.e., the 14 days prior to the baseline visit and the week 16 visit). The score ranges from 0 to 1. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS Mean SE from ANCOVA.'}, {'measure': 'Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.'}, {'measure': 'Part A: Change From Baseline in Total Score as Measured by the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) Version 2.0 Caregiver Version (PEESSv2.0-C) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The PEESSv2.0-C is a caregiver-reported outcome measure that assesses the frequency and severity of EoE symptoms among pediatric participants. The PEESSv2.0-C consists of 20 items and has a one-month recall period. Each item had a 0-4 scale, which was transformed to 0-100 as follows: 0 = 0, 1 = 25, 2 = 50, 3 = 75, 4 = 100. The mean total PEESSv2.0 score was computed as the sum of all the item scores over the number of items answered. The total PEESSv2.0-C score ranges from 0 to 100 where higher scores indicate greater symptom burden among pediatric EoE participants. Values after first rescue treatment use were set to missing (censoring). WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the MI approach was used for the missing data due to other reasons. LS mean SE from ANCOVA model.'}, {'measure': 'Part A: Concentration of Functional Dupilumab in Serum at Baseline, Week 4 and 16', 'timeFrame': 'Baseline, Week 4 and 16', 'description': 'Concentration of functional dupilumab in serum at Baseline, Week 4 and 16 was reported in this outcome measure.'}, {'measure': 'Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils/High Power Field at Week 52', 'timeFrame': 'At Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.'}, {'measure': 'Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 52', 'timeFrame': 'At Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.'}, {'measure': 'Part B: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.'}, {'measure': 'Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean grade scores summed over the 3 regions was the final score used in primary analysis, the mean grade score ranged from 0 to 3, with higher score indicating more severe.'}, {'measure': 'Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \\& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.'}, {'measure': 'Part B: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores possibly ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.'}, {'measure': 'Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.'}, {'measure': 'Part B: Number of Sign-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)', 'timeFrame': 'Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.'}, {'measure': 'Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measured the occurrence of signs of EoE and was completed once daily via an electronic diary.'}, {'measure': 'Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measured occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.'}, {'measure': 'Part B: Number of Symptom-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)', 'timeFrame': 'Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \\<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food.'}, {'measure': 'Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \\<12 years of age. The PESQ-P measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.'}, {'measure': 'Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.'}, {'measure': 'Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at post-baseline relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.'}, {'measure': 'Part B: Change From Baseline in Body Weight for Age Percentile at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Body weight for age percentile was calculated based on the growth charts from the Centers for Disease Control and Prevention (CDC) for ages 0 to 20 years (for ages 2 to \\<12 years) and World Health Organization (WHO) growth charts for ages 0 to \\<2 years (for ages 1 to \\<2 years). These charts included a set of smoothed percentiles along with CDC LMS (Lambda-Mu-Sigma) parameters to allow the calculation of percentiles.'}, {'measure': 'Part B: Change From Baseline in Body Mass Index (BMI) for Age Z-score for Participants ≥2 Years of Age at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'BMI for age z-score indicates how much higher or lower a participant\'s BMI for age is relative to a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in BMI for age z-score (ie, increase in the standard deviation \\[SD\\] from the reference growth chart) indicates an increase in BMI for age relative to the reference.'}, {'measure': 'Part B: Change From Baseline in Weight for Age Z-score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Weight for age z-score indicates how much higher or lower a participant\'s weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and World Health Organization (WHO) growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference.'}, {'measure': 'Part B: Change From Baseline in Body Weight From Height Z-score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Weight for height z-score indicates how much higher or lower a participant\'s weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and WHO growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference.'}, {'measure': 'Part B: Concentration of Functional Dupilumab in Serum at Week 32 and 52', 'timeFrame': 'Week 32 and 52', 'description': 'Concentration of functional dupilumab in serum at Week 32 and 52 was reported in this outcome measure.'}, {'measure': 'Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': "An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate."}, {'measure': 'Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug', 'timeFrame': 'From Week 16 up to Week 52 in Part B', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate."}, {'measure': 'Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.'}, {'measure': 'Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) by Maximum Titer Category', 'timeFrame': 'From Baseline up to Week 16 in Part A', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.'}, {'measure': 'Part B: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response and Titer', 'timeFrame': 'From Week 16 up to Week 52 in Part B', 'description': 'Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \\<1000, moderate as 1000 to 10000 and high as \\>10000.\n\nNo participant exhibited a treatment-emergent ADA response in Part B and titer was not reported.'}, {'measure': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf At Week 100', 'timeFrame': 'At Week 100'}, {'measure': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf At Week 160', 'timeFrame': 'At Week 160'}, {'measure': 'Part C: Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) From Baseline to Week 100', 'timeFrame': 'Baseline to Week 100'}, {'measure': 'Part C: Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) From Baseline to Week 160', 'timeFrame': 'Baseline to Week 160'}, {'measure': 'Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 100', 'timeFrame': 'Baseline to Week 100'}, {'measure': 'Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 160', 'timeFrame': 'Baseline to Week 160'}, {'measure': 'Part C: Absolute Change in EoE-EREFS From Baseline to Week 100', 'timeFrame': 'Baseline to Week 100'}, {'measure': 'Part C: Absolute Change in EoE-EREFS From Baseline to Week 160', 'timeFrame': 'Baseline to Week 160'}, {'measure': 'Part C: Change in Total Score as Measured by the PEESSv2.0- Caregiver Version Questionnaire From Baseline to Week 100', 'timeFrame': 'Baseline to Week 100', 'description': 'The PEESSv2.0-C is a caregiver-reported outcome measure that assesses the frequency and severity of EoE symptoms among pediatric participants. The PEESSv2.0-C consists of 20 items and has a one-month recall period. Each item had a 0-4 scale, which was transformed to 0-100 as follows: 0 = 0, 1 = 25, 2 = 50, 3 = 75, 4 = 100. The mean total PEESSv2.0 score was computed as the sum of all the item scores over the number of items answered. The total PEESSv2.0-C score ranges from 0 to 100 where higher scores indicate greater symptom burden among pediatric EoE participants.'}, {'measure': 'Part C: NES for the Relative Change in the EDP Transcriptome Signature From Baseline to Week 100', 'timeFrame': 'Baseline to Week 100', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.'}, {'measure': 'Part C: NES for the Relative Change in the EDP Transcriptome Signature From Baseline to Week 160', 'timeFrame': 'Baseline to Week 160', 'description': 'A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.'}, {'measure': 'Part C: NES for the Relative Change in the Type 2 Inflammation Transcriptome Signature Baseline to Week 100', 'timeFrame': 'Baseline to Week 100'}, {'measure': 'Part C: NES for the Relative Change in the Type 2 Inflammation Transcriptome Signature From Baseline to Week 160', 'timeFrame': 'Baseline to Week 160'}, {'measure': 'Part C: Change in Body Weight for Age Percentile From Baseline up to Week 100', 'timeFrame': 'Baseline up to Week 100', 'description': 'Body weight for age percentile was calculated based on the growth charts from the Centers for Disease Control and Prevention (CDC) for ages 0 to 20 years (for ages 2 to \\<12 years) and World Health Organization (WHO) growth charts for ages 0 to \\<2 years (for ages 1 to \\<2 years). These charts included a set of smoothed percentiles along with CDC LMS (Lambda-Mu-Sigma) parameters to allow the calculation of percentiles.'}, {'measure': 'Part C: Change in Body Mass Index for Age Z-score From Baseline up to Week 100', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.'}, {'measure': 'Part C: Change in Weight for Age Z-score From Baseline up to Week 100', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.'}, {'measure': 'Part C: Change in Weight for Age Z-score From Baseline up to Week 160', 'timeFrame': 'Baseline up to Week 160', 'description': "Weight for age z-score indicates how much higher or lower a participant's weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and World Health Organization (WHO) growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference."}, {'measure': 'Part C: Change in Weight for Height Z-score From Baseline up to Week 100', 'timeFrame': 'Baseline up to Week 100', 'description': 'Difference in the 100-week change from baseline in Weight for height Z-score. Weight for height Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \\[CDC\\] for ages 0 to 20 years \\[for ages 2 to \\<12 years\\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.'}, {'measure': 'Part C: Change in Weight for Height Z-score From Baseline up to Week 160', 'timeFrame': 'Baseline up to Week 160', 'description': "Weight for height z-score indicates how much higher or lower a participant's weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \\[for ages 2 to \\<12 years\\] and WHO growth charts for ages 0 to \\<2 years \\[for ages 1 to \\<2 years\\]). An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference."}, {'measure': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eos/Hpf (400×) at Week 100', 'timeFrame': 'At Week 100'}, {'measure': 'Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eos/Hpf (400×) at Week 160', 'timeFrame': 'At Week 160'}, {'measure': 'Part C: Percentage of Participants (With Food Elimination Diet Regimens at Baseline) That Have a Re-introduction of a Previously Eliminated Food Group From Baseline up to Week 100', 'timeFrame': 'Baseline up to Week 100'}, {'measure': 'Part C: Percentage of Participants (With Food Elimination Diet Regimens at Baseline) That Have a Re-introduction of a Previously Eliminated Food Group From Baseline up to Week 160', 'timeFrame': 'Baseline up to Week 160'}, {'measure': 'Part C: Number of Participants With TEAEs', 'timeFrame': 'Up to Week 152'}, {'measure': 'Part C: Number of Participants With Treatment-emergent SAEs', 'timeFrame': 'Up to Week 152'}, {'measure': 'Part C: Number of Participants With Treatment-emergent AESIs', 'timeFrame': 'Up to Week 152'}, {'measure': 'Part C: Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Treatment', 'timeFrame': 'Up to Week 152'}, {'measure': 'Part C: Number of Participants With Treatment-emergent ADA Responses', 'timeFrame': 'From Week 52 up to Week 152'}, {'measure': 'Part C: Concentration of Functional Dupilumab in Serum at Week 100', 'timeFrame': 'At Week 100'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis (EoE)']}, 'referencesModule': {'references': [{'pmid': '38924731', 'type': 'DERIVED', 'citation': 'Chehade M, Dellon ES, Spergel JM, Collins MH, Rothenberg ME, Pesek RD, Hirano I, Liu R, Laws E, Mortensen E, Martincova R, Shabbir A, McCann E, Kamal MA, Kosloski MP, Hamilton JD, Samuely C, Lim WK, Wipperman MF, Farrell A, Patel N, Yancopoulos GD, Glotfelty L, Maloney J. Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 Years of Age. N Engl J Med. 2024 Jun 27;390(24):2239-2251. doi: 10.1056/NEJMoa2312282.'}]}, 'descriptionModule': {'briefSummary': 'The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria.\n\nThe Secondary objectives are:\n\n* To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS)\n* To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE\n* To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation\n* To study the effects of dupilumab on the type 2 inflammation gene expression signature\n* To evaluate the concentration-time profile of functional dupilumab in serum in this population\n* To assess efficacy of long-term (up to 160 weeks) dupilumab treatment\n* To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study\n* To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment\n* To evaluate the impact of dupilumab treatment on EoE signs and symptoms', 'detailedDescription': 'This is a 3-part study:\n\n* Part A: Double-blind 16-week treatment period\n* Part B: 36-week extended active treatment period\n* Part C: Up to108 weeks open-label extension period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. A documented diagnosis of eosinophilic esophagitis (EoE)\n2. Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration\n\nKey Exclusion Criteria:\n\n1. Body weight \\<5 kg or ≥60 kg at screening\n2. Other causes of esophageal eosinophilia\n3. Active Helicobacter pylori\n4. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery\n5. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening\n6. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy\n7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure\n8. Active parasitic infection or suspected parasitic infection\n9. Known or suspected immunodeficiency disorder\n\nKey Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in protocol):\n\n1. Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country\n2. Patients who, during their previous participation in this clinical trial, developed an SAE and/or AE deemed related to dupilumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient\n3. Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or prior to receiving rescue treatment Note: If the endoscopy with biopsies could not occur due to COVID-19 restrictions and rescue treatment was needed to be initiated without delay, these patients will be eligible to participate in Part C\n4. Patients who became pregnant during their previous participation in this dupilumab clinical trial\n5. Patients who, during their previous participation in this trial, were prematurely withdrawn because of a protocol violation, poor compliance, or inability to complete required study assessments\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04394351', 'acronym': 'EoE KIDS', 'briefTitle': 'Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': 'R668-EE-1877'}, 'secondaryIdInfos': [{'id': '2019-003078-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A - High Dose', 'description': 'Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight', 'interventionNames': ['Drug: Dupilumab', 'Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A - Low Dose', 'description': 'Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight', 'interventionNames': ['Drug: Dupilumab', 'Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - High Dose', 'description': 'Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight', 'interventionNames': ['Drug: Dupilumab', 'Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - Low Dose', 'description': 'Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight', 'interventionNames': ['Drug: Dupilumab', 'Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C - High Dose', 'description': 'Part C consists of up to 108-week open-label extension period. All patients will receive higher exposure dupilumab subcutaneous (SC) administration at tiered dosing regimens based on body weight. No matching placebo administered in Part C.', 'interventionNames': ['Drug: Dupilumab']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['•DUPIXENT', '•REGN668', '•SAR231893'], 'description': 'Single-use, prefilled syringe', 'armGroupLabels': ['Part A - High Dose', 'Part A - Low Dose', 'Part B - High Dose', 'Part B - Low Dose', 'Part C - High Dose']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Matching formulation and regimen (depending on the weight tier) as dupilumab without the active substance', 'armGroupLabels': ['Part A - High Dose', 'Part A - Low Dose', 'Part B - High Dose', 'Part B - Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Regeneron Study Site', 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