Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT03568318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults: Placebo + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 264, 'otherNumAffected': 99, 'seriousNumAtRisk': 264, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Adults: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical 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'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'LIGAMENT RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ADENOCARCINOMA OF COLON', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HYDRONEPHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'STATUS ASTHMATICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'DERMATITIS EXFOLIATIVE GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ERYTHRODERMIC ATOPIC DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '31.4'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '70.0'}, {'value': '77.1', 'groupId': 'OG002', 'lowerLimit': '72.3', 'upperLimit': '81.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.6', 'ciLowerLimit': '43.8', 'ciUpperLimit': '57.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.1', 'ciLowerLimit': '30.8', 'ciUpperLimit': '45.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population for the main study (ITT\\_M) includes all participants who were randomized in the main study (adults and adolescents). Non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 pandemic (COVID-19) (NRI-C) was used.\n\nThe pre-specified primary analysis included participants enrolled in the main study only; Efficacy analyses of adolescent participants were conducted separately and are reported below.'}, {'type': 'PRIMARY', 'title': 'Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '14.4'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '45.2'}, {'value': '58.6', 'groupId': 'OG002', 'lowerLimit': '53.0', 'upperLimit': '64.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.6', 'ciLowerLimit': '41.1', 'ciUpperLimit': '54.0', 'estimateComment': 'Response rate difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.5', 'ciLowerLimit': '22.1', 'ciUpperLimit': '34.9', 'estimateComment': 'Response rate difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No inflammatory signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '19.0'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '57.5'}, {'value': '63.9', 'groupId': 'OG002', 'lowerLimit': '58.4', 'upperLimit': '69.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.8', 'ciLowerLimit': '41.9', 'ciUpperLimit': '55.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.8', 'ciLowerLimit': '29.7', 'ciUpperLimit': '43.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '17.0'}, {'value': '42.8', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '48.4'}, {'value': '63.1', 'groupId': 'OG002', 'lowerLimit': '57.6', 'upperLimit': '68.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.9', 'ciLowerLimit': '43.3', 'ciUpperLimit': '56.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.5', 'ciLowerLimit': '22.8', 'ciUpperLimit': '36.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '19.0'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '46.7', 'upperLimit': '58.2'}, {'value': '65.6', 'groupId': 'OG002', 'lowerLimit': '60.2', 'upperLimit': '71.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.6', 'ciLowerLimit': '43.8', 'ciUpperLimit': '57.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.4', 'ciLowerLimit': '30.4', 'ciUpperLimit': '44.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '18.8'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '64.2'}, {'value': '72.4', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '77.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.6', 'ciLowerLimit': '51.2', 'ciUpperLimit': '63.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.8', 'ciLowerLimit': '37.0', 'ciUpperLimit': '50.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '9.8'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '36.2'}, {'value': '44.1', 'groupId': 'OG002', 'lowerLimit': '38.5', 'upperLimit': '49.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.2', 'ciLowerLimit': '31.0', 'ciUpperLimit': '43.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '18.1', 'ciUpperLimit': '29.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7.4'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '33.4'}, {'value': '43.8', 'groupId': 'OG002', 'lowerLimit': '38.1', 'upperLimit': '49.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.8', 'ciLowerLimit': '32.8', 'ciUpperLimit': '44.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.3', 'ciLowerLimit': '17.7', 'ciUpperLimit': '28.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '15.7'}, {'value': '22.6', 'groupId': 'OG002', 'lowerLimit': '17.8', 'upperLimit': '27.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.2', 'ciLowerLimit': '16.3', 'ciUpperLimit': '26.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored from 0 \\[none\\], to 3 \\[severe\\]) for redness, thickness, scratching, and lichenification.\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nThe percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '5.0'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '15.9'}, {'value': '19.2', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '23.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.2', 'ciLowerLimit': '11.3', 'ciUpperLimit': '21.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '4.9', 'ciUpperLimit': '13.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.07', 'groupId': 'OG000', 'lowerLimit': '-31.64', 'upperLimit': '-18.49'}, {'value': '-58.14', 'groupId': 'OG001', 'lowerLimit': '-64.24', 'upperLimit': '-52.05'}, {'value': '-66.85', 'groupId': 'OG002', 'lowerLimit': '-72.99', 'upperLimit': '-60.72'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.79', 'ciLowerLimit': '-50.46', 'ciUpperLimit': '-33.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.417', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.08', 'ciLowerLimit': '-41.72', 'ciUpperLimit': '-24.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.403', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Topical Corticosteroids', 'description': 'Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.86', 'groupId': 'OG000', 'lowerLimit': '-50.09', 'upperLimit': '-41.63'}, {'value': '-77.99', 'groupId': 'OG001', 'lowerLimit': '-81.87', 'upperLimit': '-74.10'}, {'value': '-87.31', 'groupId': 'OG002', 'lowerLimit': '-91.20', 'upperLimit': '-83.41'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.45', 'ciLowerLimit': '-46.68', 'ciUpperLimit': '-36.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.662', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'groupDescription': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.13', 'ciLowerLimit': '-37.35', 'ciUpperLimit': '-26.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.659', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '41.6'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '51.1', 'upperLimit': '75.5'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '74.9', 'upperLimit': '93.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.1', 'ciLowerLimit': '38.8', 'ciUpperLimit': '67.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.7', 'ciLowerLimit': '16.3', 'ciUpperLimit': '49.0', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population for adolescents (ITT\\_A) consists of all adolescent participants who were randomized in the main study or the adolescent sub-study. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '19.1'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '26.0', 'upperLimit': '50.6'}, {'value': '67.4', 'groupId': 'OG002', 'lowerLimit': '55.5', 'upperLimit': '79.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.4', 'ciLowerLimit': '41.4', 'ciUpperLimit': '69.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.3', 'ciLowerLimit': '12.1', 'ciUpperLimit': '40.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population for adolescents (ITT\\_A) consists of all adolescent participants who were randomized in the main study or the adolescent sub-study. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '31.6'}, {'value': '45.6', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '58.5'}, {'value': '51.8', 'groupId': 'OG002', 'lowerLimit': '38.7', 'upperLimit': '64.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.5', 'ciLowerLimit': '14.1', 'ciUpperLimit': '46.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.5', 'ciLowerLimit': '8.2', 'ciUpperLimit': '40.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '30.7'}, {'value': '48.3', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '61.0'}, {'value': '73.6', 'groupId': 'OG002', 'lowerLimit': '62.3', 'upperLimit': '84.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.0', 'ciLowerLimit': '37.3', 'ciUpperLimit': '66.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.1', 'ciLowerLimit': '11.1', 'ciUpperLimit': '43.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '33.5'}, {'value': '45.6', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '58.5'}, {'value': '46.4', 'groupId': 'OG002', 'lowerLimit': '33.4', 'upperLimit': '59.5'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.5', 'ciLowerLimit': '6.9', 'ciUpperLimit': '40.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.7', 'ciLowerLimit': '6.2', 'ciUpperLimit': '39.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '39.7'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '67.5'}, {'value': '78.3', 'groupId': 'OG002', 'lowerLimit': '67.9', 'upperLimit': '88.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.3', 'ciLowerLimit': '34.1', 'ciUpperLimit': '64.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '9.4', 'ciUpperLimit': '43.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '16.8'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '45.8'}, {'value': '51.7', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '64.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.5', 'ciLowerLimit': '27.8', 'ciUpperLimit': '55.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.4', 'ciLowerLimit': '10.3', 'ciUpperLimit': '38.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '16.8'}, {'value': '34.2', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '46.3'}, {'value': '45.0', 'groupId': 'OG002', 'lowerLimit': '32.4', 'upperLimit': '57.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.9', 'ciLowerLimit': '20.6', 'ciUpperLimit': '49.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.5', 'ciLowerLimit': '10.4', 'ciUpperLimit': '38.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '21.9'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '36.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '7.8', 'ciUpperLimit': '31.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is used to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. and the severity score is calculated as the sum of the intensity scores (scored from 0 \\[none\\], to 3 \\[severe\\]) for redness, thickness, scratching, and lichenification.\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.\n\nThe percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '17.3'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '16.1'}, {'value': '16.1', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '25.7'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '18.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '9.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.96', 'groupId': 'OG000', 'lowerLimit': '-49.87', 'upperLimit': '-16.05'}, {'value': '-59.34', 'groupId': 'OG001', 'lowerLimit': '-75.78', 'upperLimit': '-42.90'}, {'value': '-49.02', 'groupId': 'OG002', 'lowerLimit': '-65.35', 'upperLimit': '-32.69'}]}]}], 'analyses': [{'pValue': '0.180', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.05', 'ciLowerLimit': '-39.59', 'ciUpperLimit': '7.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.956', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.38', 'ciLowerLimit': '-49.97', 'ciUpperLimit': '-2.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.986', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-53.53', 'groupId': 'OG000', 'lowerLimit': '-61.23', 'upperLimit': '-45.82'}, {'value': '-77.90', 'groupId': 'OG001', 'lowerLimit': '-85.36', 'upperLimit': '-70.44'}, {'value': '-89.22', 'groupId': 'OG002', 'lowerLimit': '-96.49', 'upperLimit': '-81.95'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.69', 'ciLowerLimit': '-46.28', 'ciUpperLimit': '-25.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.354', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.37', 'ciLowerLimit': '-35.10', 'ciUpperLimit': '-13.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.423', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults: Placebo + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids (TCS) following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'FG001', 'title': 'Adults: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'FG002', 'title': 'Adults: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'FG003', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'FG004', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'FG005', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized into study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '260'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '60'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '260'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '250'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ongoing at Time of Analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 171 clinical sites in 22 countries in the Asia-Pacific region, Europe, Middle East, North America, and Oceania.\n\nThe study included a 16-week double-blind treatment period followed by a blinded extension period (ongoing).\n\nThe first 810 adults and adolescents enrolled constituted the Main Study; additional adolescents were enrolled in the Adolescent Substudy to ensure enrollment of a total of 180 adolescent participants overall.\n\nResults are reported up to Week 16.', 'preAssignmentDetails': 'Participants were randomized equally into 1 of 3 treatment groups, stratified by disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis \\[vIGA-AD\\] moderate \\[3\\] vs severe \\[4\\]), geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and age (adolescent \\[ages 12 to 17\\] vs adult \\[ages 18 to 75\\]). Randomization for the adolescent substudy was stratified by disease severity (vIGA-AD 3 vs vIGA-AD 4) and geographic region (US/Puerto Rico/Canada vs Other).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults: Placebo + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG001', 'title': 'Adults: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG002', 'title': 'Adults: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG003', 'title': 'Adolescents: Placebo + Topical Corticosteroids', 'description': 'Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG004', 'title': 'Adolescents: Upadacitinib 15 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG005', 'title': 'Adolescents: Upadacitinib 30 mg + Topical Corticosteroids', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '14.08', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '13.29', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '14.82', 'groupId': 'BG002'}, {'value': '15.1', 'spread': '1.85', 'groupId': 'BG003'}, {'value': '15.4', 'spread': '1.65', 'groupId': 'BG004'}, {'value': '15.3', 'spread': '1.86', 'groupId': 'BG005'}, {'value': '32.8', 'spread': '15.29', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': '12 - 14 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '58', 'groupId': 'BG006'}]}, {'title': '15 - 17 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '125', 'groupId': 'BG006'}]}, {'title': '18 - < 40 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '490', 'groupId': 'BG006'}]}, {'title': '40 - < 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '259', 'groupId': 'BG006'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '388', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '580', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '896', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '200', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '692', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Main Study', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '901', 'groupId': 'BG006'}]}, {'title': 'Adolescent Substudy', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': 'US/Puerto Rico/Canada', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '362', 'groupId': 'BG006'}]}, {'title': 'Japan', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}, {'title': 'China', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '504', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'title': '3 (Moderate)', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '456', 'groupId': 'BG006'}]}, {'title': '4 (Severe)', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '512', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The vIGA-AD was used to assess the severity of atopic dermatitis based on lesion appearance on the following scale:\n\n* 0-Clear: No inflammatory signs of AD;\n* 1-Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2-Mild: Slight but definite erythema, induration/papulation and/or lichenification. No oozing or crusting;\n* 3-Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4-Severe: Marked erythema, induration/papulation and/or lichenification, oozing or crusting may be present.', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '30.06', 'spread': '12.860', 'groupId': 'BG000'}, {'value': '29.03', 'spread': '11.925', 'groupId': 'BG001'}, {'value': '29.68', 'spread': '11.993', 'groupId': 'BG002'}, {'value': '30.25', 'spread': '12.105', 'groupId': 'BG003'}, {'value': '29.59', 'spread': '11.683', 'groupId': 'BG004'}, {'value': '28.68', 'spread': '10.143', 'groupId': 'BG005'}, {'value': '29.58', 'spread': '12.082', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Duration since Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '967', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '25.986', 'spread': '15.5650', 'groupId': 'BG000'}, {'value': '24.511', 'spread': '14.0363', 'groupId': 'BG001'}, {'value': '24.617', 'spread': '16.6107', 'groupId': 'BG002'}, {'value': '12.315', 'spread': '4.2769', 'groupId': 'BG003'}, {'value': '11.370', 'spread': '5.0674', 'groupId': 'BG004'}, {'value': '12.244', 'spread': '3.9262', 'groupId': 'BG005'}, {'value': '22.584', 'spread': '14.9374', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-29', 'size': 15563436, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-07T18:45', 'hasProtocol': True}, {'date': '2020-06-03', 'size': 750793, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-07T18:47', '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': 1533}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04159597', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-10-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-03-08', 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No inflammatory signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.'}], 'secondaryOutcomes': [{'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored from 0 \\[none\\], to 3 \\[severe\\]) for redness, thickness, scratching, and lichenification.\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nThe percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.'}, {'measure': 'Main Study: Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is used to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. and the severity score is calculated as the sum of the intensity scores (scored from 0 \\[none\\], to 3 \\[severe\\]) for redness, thickness, scratching, and lichenification.\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.\n\nThe percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.'}, {'measure': 'Adolescents: Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Upadacitinib'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '40900410', 'type': 'DERIVED', 'citation': 'Irvine AD, Prajapati VH, Guttman-Yassky E, Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Gold LFS, de Bruin-Weller M, Bieber T, Kabashima K, Rosmarin D, Sancho C, Calimlim BM, Grada A, Yang Y, Wu X, Levy G, Raymundo EM, Teixeira HD, Silverberg JI. Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks. Am J Clin Dermatol. 2025 Nov;26(6):1003-1016. doi: 10.1007/s40257-025-00975-3. Epub 2025 Sep 3.'}, {'pmid': '40875187', 'type': 'DERIVED', 'citation': 'Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.'}, {'pmid': '39441580', 'type': 'DERIVED', 'citation': 'Paller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696.'}, {'pmid': '37691437', 'type': 'DERIVED', 'citation': 'Silverberg JI, Leshem YA, Calimlim BM, McDonald J, Litcher-Kelly L. Psychometric evaluation of the Worst Pruritus Numerical Rating Scale (NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS). Curr Med Res Opin. 2023 Oct;39(10):1289-1296. doi: 10.1080/03007995.2023.2251883. Epub 2023 Sep 13.'}, {'pmid': '37247226', 'type': 'DERIVED', 'citation': 'Thyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21.'}, {'pmid': '37043227', 'type': 'DERIVED', 'citation': 'Paller AS, Ladizinski B, Mendes-Bastos P, Siegfried E, Soong W, Prajapati VH, Lio P, Thyssen JP, Simpson EL, Platt AM, Raymundo EM, Liu J, Calimlim BM, Huang X, Gu Y, Hu X, Yang Y, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. 2023 May 1;159(5):526-535. doi: 10.1001/jamadermatol.2023.0391.'}, {'pmid': '36754548', 'type': 'DERIVED', 'citation': 'Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.'}, {'pmid': '36333616', 'type': 'DERIVED', 'citation': 'Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.'}, {'pmid': '35714786', 'type': 'DERIVED', 'citation': 'Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.'}, {'pmid': '34023009', 'type': 'DERIVED', 'citation': 'Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21.'}], 'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M16-047', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.', 'detailedDescription': 'This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.\n\nUpon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).\n\nApproximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.\n\nRandomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis \\[vIGA-AD\\] score of moderate \\[3\\] versus severe \\[4\\]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent \\[ages 12 to 17\\] versus adult \\[ages 18 to 75\\]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate \\[vIGA-AD 3\\] versus severe \\[vIGA-AD 4\\]) and by geographic region (US/Puerto Rico/Canada and Other).\n\nAt Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent \\[ages 12 to 17\\] versus adult \\[ages 18 to 75\\]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).\n\nStarting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and \\< 18 years of age\n* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.\n* Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.\n* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.\n* Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit\n\nExclusion Criteria:\n\n* Prior exposure to any Janus kinase (JAK) inhibitor\n* Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study\n* Requirement of prohibited medications during the study\n* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions\n* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study"}, 'identificationModule': {'nctId': 'NCT03568318', 'acronym': 'AD Up', 'briefTitle': 'A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'M16-047'}, 'secondaryIdInfos': [{'id': '2017-005126-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / Upadacitinib + Topical Corticosteroids', 'description': 'Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.', 'interventionNames': ['Drug: Placebo', 'Drug: Upadacitinib', 'Drug: Topical corticosteroids (TCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 15 mg QD + Topical Corticosteroids', 'description': 'Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Topical corticosteroids (TCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 30 mg QD + Topical Corticosteroids', 'description': 'Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Topical corticosteroids (TCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Long-Term Extension', 'description': 'Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Topical corticosteroids (TCS)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets taken orally once a day', 'armGroupLabels': ['Placebo / Upadacitinib + Topical Corticosteroids']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['ABT-494', 'RINVOQ™'], 'description': 'Tablets taken orally once a day', 'armGroupLabels': ['Long-Term Extension', 'Placebo / Upadacitinib + Topical Corticosteroids', 'Upadacitinib 15 mg QD + Topical Corticosteroids', 'Upadacitinib 30 mg QD + Topical Corticosteroids']}, {'name': 'Topical corticosteroids (TCS)', 'type': 'DRUG', 'description': 'Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.\n\nRecommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.', 'armGroupLabels': ['Long-Term Extension', 'Placebo / Upadacitinib + Topical Corticosteroids', 'Upadacitinib 15 mg QD + Topical Corticosteroids', 'Upadacitinib 30 mg QD + Topical Corticosteroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Derm Ctr /ID# 200548', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209-6802', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center AL /ID# 201865', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35218', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'ACCEL Research Sites /ID# 213364', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36605-3004', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Advanced Dermatology and Skin Care Centre /ID# 213550', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance Dermatology and MOHs Center, PC /ID#200540', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053-4061', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc. /ID# 200546', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85255-4134', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clear Dermatology & Aesthetics Center /ID# 201257', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona /ID# 201059', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield Derma & Skin Cance /ID# 200892', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Mosaic Dermatology /ID# 200553', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92697-1385', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine /ID# 200902', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research /ID# 200593', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}