Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 5:00 PM
Study NCT ID:
NCT04345367
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2020-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634427', 'term': 'abrocitinib'}, {'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30)', 'description': 'An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.', 'otherNumAtRisk': 362, 'deathsNumAtRisk': 362, 'otherNumAffected': 203, 'seriousNumAtRisk': 362, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 144, 'seriousNumAtRisk': 365, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Natural killer cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '53.4'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '30.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.6', 'ciLowerLimit': '15.8', 'ciUpperLimit': '29.5', 'pValueComment': 'Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.', 'estimateComment': 'The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '33.2'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '18.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '8.2', 'ciUpperLimit': '20.0', 'pValueComment': 'CMH method adjusted by baseline disease severity.', 'estimateComment': 'The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI-90 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '59.5'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '36.8', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '5.3', 'ciUpperLimit': '19.7', 'pValueComment': 'CMH method adjusted by baseline disease severity.', 'estimateComment': 'The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '14.9'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '9.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '50.5'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '20.9', 'upperLimit': '29.9'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '52.8'}, {'value': '33.6', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '38.5'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '63.5'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '50.9'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000', 'lowerLimit': '49.4', 'upperLimit': '59.8'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '42.5', 'upperLimit': '52.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '0.2', 'ciUpperLimit': '8.7', 'estimateComment': 'Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '13.2', 'ciUpperLimit': '26.9', 'estimateComment': 'Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '6.9', 'ciUpperLimit': '21.1', 'estimateComment': 'Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '5.5', 'ciUpperLimit': '20.0', 'estimateComment': 'Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '14.3', 'estimateComment': 'Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 8, 12, 20 and 26', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '34.1'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '25.5'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '62.8'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '41.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '75.7'}, {'value': '52.8', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '57.9'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '80.7'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '56.4', 'upperLimit': '66.4'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '81.7'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '72.6'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '80.6'}, {'value': '71.1', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '75.7'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '77.7'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '76.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '1.8', 'ciUpperLimit': '14.4', 'estimateComment': 'Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.9', 'ciLowerLimit': '13.8', 'ciUpperLimit': '28.0', 'estimateComment': 'Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.4', 'ciLowerLimit': '11.4', 'ciUpperLimit': '25.3', 'estimateComment': 'Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.9', 'ciLowerLimit': '8.2', 'ciUpperLimit': '21.5', 'estimateComment': 'Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '3.0', 'ciUpperLimit': '16.0', 'estimateComment': 'Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '11.5', 'estimateComment': 'Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '7.2', 'estimateComment': 'Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20 and 26', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26", 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '18.0'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '9.8'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '43.0'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '21.5'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000', 'lowerLimit': '44.9', 'upperLimit': '55.3'}, {'value': '30.9', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '35.7'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '57.0'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '40.9'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '50.2', 'upperLimit': '60.5'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '37.4', 'upperLimit': '47.6'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '65.1'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '56.0'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '60.8'}, {'value': '51.1', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '56.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '2.8', 'ciUpperLimit': '11.7', 'estimateComment': 'Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '14.3', 'ciUpperLimit': '26.9', 'estimateComment': 'Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.5', 'ciLowerLimit': '12.5', 'ciUpperLimit': '26.4', 'estimateComment': 'Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '8.7', 'ciUpperLimit': '23.0', 'estimateComment': 'Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '5.9', 'ciUpperLimit': '20.2', 'estimateComment': 'Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '2.0', 'ciUpperLimit': '16.4', 'estimateComment': 'Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '11.8', 'estimateComment': 'Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20 and 26', 'description': 'IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '14.4'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '5.9'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '18.8'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '11.5'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '26.4'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '13.9'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '31.0'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '15.3'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '33.2'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '19.3'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '38.1'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '16.8'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '41.3'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '17.8'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '43.6'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '20.8'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '45.2'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '22.8'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '45.3'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '24.4'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '36.3', 'upperLimit': '46.7'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '24.4'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '38.8', 'upperLimit': '49.2'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '25.7'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '50.8'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '27.6'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '53.8'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '30.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '3.1', 'ciUpperLimit': '11.1', 'estimateComment': 'Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.7', 'ciUpperLimit': '11.3', 'estimateComment': 'Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '6.0', 'ciUpperLimit': '16.8', 'estimateComment': 'Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.5', 'ciLowerLimit': '8.8', 'ciUpperLimit': '20.3', 'estimateComment': 'Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '6.9', 'ciUpperLimit': '19.0', 'estimateComment': 'Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.9', 'ciLowerLimit': '13.8', 'ciUpperLimit': '26.0', 'estimateComment': 'Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.1', 'ciLowerLimit': '15.9', 'ciUpperLimit': '28.3', 'estimateComment': 'Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.7', 'ciLowerLimit': '15.2', 'ciUpperLimit': '28.1', 'estimateComment': 'Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of other', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '14.7', 'ciUpperLimit': '27.9', 'estimateComment': 'Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '13.3', 'ciUpperLimit': '26.6', 'estimateComment': 'Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '14.6', 'ciUpperLimit': '27.9', 'estimateComment': 'Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '15.8', 'ciUpperLimit': '29.2', 'estimateComment': 'Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.4', 'ciLowerLimit': '15.6', 'ciUpperLimit': '29.2', 'estimateComment': 'Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.9', 'ciLowerLimit': '16.0', 'ciUpperLimit': '29.9', 'estimateComment': 'Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '63.3'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '45.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000', 'lowerLimit': '60.9', 'upperLimit': '70.7'}, {'value': '52.7', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '57.9'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '70.9'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '66.5'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '72.1'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '68.6'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '70.2'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '68.1'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '63.2', 'upperLimit': '72.9'}, {'value': '63.1', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '68.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.3', 'ciLowerLimit': '10.1', 'ciUpperLimit': '24.5', 'estimateComment': 'Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '6.0', 'ciUpperLimit': '20.1', 'estimateComment': 'Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '11.4', 'estimateComment': 'Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '10.5', 'estimateComment': 'Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '9.0', 'estimateComment': 'Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '11.9', 'estimateComment': 'Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 8, 12, 16, 20 and 26', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '14.0'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-42.7', 'groupId': 'OG000', 'lowerLimit': '-46.0', 'upperLimit': '-39.4'}, {'value': '-33.4', 'groupId': 'OG001', 'lowerLimit': '-36.7', 'upperLimit': '-30.0'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-62.0', 'groupId': 'OG000', 'lowerLimit': '-65.5', 'upperLimit': '-58.5'}, {'value': '-49.5', 'groupId': 'OG001', 'lowerLimit': '-53.0', 'upperLimit': '-46.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-74.0', 'groupId': 'OG000', 'lowerLimit': '-77.2', 'upperLimit': '-70.7'}, {'value': '-62.8', 'groupId': 'OG001', 'lowerLimit': '-66.0', 'upperLimit': '-59.7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-78.8', 'groupId': 'OG000', 'lowerLimit': '-81.9', 'upperLimit': '-75.7'}, {'value': '-69.4', 'groupId': 'OG001', 'lowerLimit': '-72.5', 'upperLimit': '-66.4'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-80.6', 'groupId': 'OG000', 'lowerLimit': '-83.5', 'upperLimit': '-77.8'}, {'value': '-73.7', 'groupId': 'OG001', 'lowerLimit': '-76.5', 'upperLimit': '-70.9'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-82.2', 'groupId': 'OG000', 'lowerLimit': '-84.8', 'upperLimit': '-79.6'}, {'value': '-76.9', 'groupId': 'OG001', 'lowerLimit': '-79.5', 'upperLimit': '-74.3'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-82.3', 'groupId': 'OG000', 'lowerLimit': '-85.0', 'upperLimit': '-79.6'}, {'value': '-79.0', 'groupId': 'OG001', 'lowerLimit': '-81.6', 'upperLimit': '-76.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.3', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '-4.6', 'estimateComment': 'Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-17.4', 'ciUpperLimit': '-7.6', 'estimateComment': 'Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.1', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '-6.6', 'estimateComment': 'Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '-5.1', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.9', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '-2.9', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '-1.7', 'estimateComment': 'Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '0.4', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26', 'description': "The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD.", 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-44.5', 'groupId': 'OG000', 'lowerLimit': '-47.0', 'upperLimit': '-42.1'}, {'value': '-33.5', 'groupId': 'OG001', 'lowerLimit': '-35.9', 'upperLimit': '-31.0'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-59.6', 'groupId': 'OG000', 'lowerLimit': '-61.9', 'upperLimit': '-57.3'}, {'value': '-46.8', 'groupId': 'OG001', 'lowerLimit': '-49.1', 'upperLimit': '-44.5'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-65.8', 'groupId': 'OG000', 'lowerLimit': '-68.2', 'upperLimit': '-63.4'}, {'value': '-55.6', 'groupId': 'OG001', 'lowerLimit': '-58.0', 'upperLimit': '-53.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-67.9', 'groupId': 'OG000', 'lowerLimit': '-70.2', 'upperLimit': '-65.6'}, {'value': '-60.6', 'groupId': 'OG001', 'lowerLimit': '-62.9', 'upperLimit': '-58.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-70.6', 'groupId': 'OG000', 'lowerLimit': '-72.8', 'upperLimit': '-68.3'}, {'value': '-64.4', 'groupId': 'OG001', 'lowerLimit': '-66.7', 'upperLimit': '-62.2'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-71.8', 'groupId': 'OG000', 'lowerLimit': '-74.1', 'upperLimit': '-69.4'}, {'value': '-66.8', 'groupId': 'OG001', 'lowerLimit': '-69.1', 'upperLimit': '-64.5'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-71.5', 'groupId': 'OG000', 'lowerLimit': '-73.9', 'upperLimit': '-69.1'}, {'value': '-68.2', 'groupId': 'OG001', 'lowerLimit': '-70.6', 'upperLimit': '-65.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.0', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '-7.6', 'estimateComment': 'Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '-9.5', 'estimateComment': 'Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '-6.8', 'estimateComment': 'Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '-4.1', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '-3.0', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-1.7', 'estimateComment': 'Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '0.1', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26', 'description': "SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.5'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.6'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.8'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.9'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.7'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-0.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.6', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.7'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.6', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-D assessed the state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-8.6', 'groupId': 'OG000', 'lowerLimit': '-9.1', 'upperLimit': '-8.2'}, {'value': '-6.7', 'groupId': 'OG001', 'lowerLimit': '-7.1', 'upperLimit': '-6.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-10.7', 'groupId': 'OG000', 'lowerLimit': '-11.1', 'upperLimit': '-10.2'}, {'value': '-9.7', 'groupId': 'OG001', 'lowerLimit': '-10.1', 'upperLimit': '-9.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-10.8', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '-10.4'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '-9.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-10.8', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '-10.3'}, {'value': '-10.1', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-9.7'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-10.3', 'groupId': 'OG000', 'lowerLimit': '-10.8', 'upperLimit': '-9.9'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '-9.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-1.3', 'estimateComment': 'Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.4', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.2', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.0', 'estimateComment': 'Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.4', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 12, 16, 20 and 26', 'description': 'DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '12.370', 'groupId': 'OG000', 'lowerLimit': '10.917', 'upperLimit': '13.822'}, {'value': '11.552', 'groupId': 'OG001', 'lowerLimit': '10.123', 'upperLimit': '12.981'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '12.567', 'groupId': 'OG000', 'lowerLimit': '11.015', 'upperLimit': '14.118'}, {'value': '10.474', 'groupId': 'OG001', 'lowerLimit': '8.951', 'upperLimit': '11.997'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '13.484', 'groupId': 'OG000', 'lowerLimit': '11.982', 'upperLimit': '14.985'}, {'value': '14.300', 'groupId': 'OG001', 'lowerLimit': '12.836', 'upperLimit': '15.764'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.818', 'ciLowerLimit': '-1.220', 'ciUpperLimit': '2.856', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.093', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '4.267', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.816', 'ciLowerLimit': '-2.914', 'ciUpperLimit': '1.281', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': "The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-14.2', 'groupId': 'OG000', 'lowerLimit': '-14.9', 'upperLimit': '-13.6'}, {'value': '-12.6', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '-12.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-14.2', 'groupId': 'OG000', 'lowerLimit': '-14.8', 'upperLimit': '-13.6'}, {'value': '-12.8', 'groupId': 'OG001', 'lowerLimit': '-13.4', 'upperLimit': '-12.2'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-13.8', 'groupId': 'OG000', 'lowerLimit': '-14.5', 'upperLimit': '-13.1'}, {'value': '-13.4', 'groupId': 'OG001', 'lowerLimit': '-14.0', 'upperLimit': '-12.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-0.7', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.5', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.5', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Quantity Hours Slept Score: Week 12', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.9'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.7'}]}]}, {'title': 'Quantity Hours Slept Score: Week 16', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Quantity Hours Slept Score: Week 26', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.6'}]}]}, {'title': 'Short of Breath or Headache score: Week 12', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.9'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '-0.4'}]}]}, {'title': 'Short of Breath or Headache score: Week 16', 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '0.3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '0.2'}]}]}, {'title': 'Short of Breath or Headache score: Week 26', 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-0.6'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '-1.2'}]}]}, {'title': 'Snoring Score: Week 12', 'categories': [{'measurements': [{'value': '-5.3', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '-3.6'}, {'value': '-3.5', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-1.8'}]}]}, {'title': 'Snoring Score: Week 16', 'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '-3.1'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-5.7', 'upperLimit': '-2.3'}]}]}, {'title': 'Snoring Score: Week 26', 'categories': [{'measurements': [{'value': '-3.9', 'groupId': 'OG000', 'lowerLimit': '-5.7', 'upperLimit': '-2.0'}, {'value': '-4.7', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '-2.9'}]}]}, {'title': 'Sleep Disturbance Score: Week 12', 'categories': [{'measurements': [{'value': '-20.5', 'groupId': 'OG000', 'lowerLimit': '-22.3', 'upperLimit': '-18.8'}, {'value': '-16.4', 'groupId': 'OG001', 'lowerLimit': '-18.1', 'upperLimit': '-14.7'}]}]}, {'title': 'Sleep Disturbance Score: Week 16', 'categories': [{'measurements': [{'value': '-21.5', 'groupId': 'OG000', 'lowerLimit': '-23.2', 'upperLimit': '-19.7'}, {'value': '-17.7', 'groupId': 'OG001', 'lowerLimit': '-19.4', 'upperLimit': '-16.0'}]}]}, {'title': 'Sleep Disturbance Score: Week 26', 'categories': [{'measurements': [{'value': '-21.2', 'groupId': 'OG000', 'lowerLimit': '-23.0', 'upperLimit': '-19.5'}, {'value': '-19.5', 'groupId': 'OG001', 'lowerLimit': '-21.2', 'upperLimit': '-17.8'}]}]}, {'title': 'Sleep Adequacy Score: Week 12', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.8'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '14.7'}]}]}, {'title': 'Sleep Adequacy Score: Week 16', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '17.4'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '14.5'}]}]}, {'title': 'Sleep Adequacy Score: Week 26', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.8'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '15.1'}]}]}, {'title': 'Sleep Somnolence Score: Week 12', 'categories': [{'measurements': [{'value': '-7.7', 'groupId': 'OG000', 'lowerLimit': '-9.1', 'upperLimit': '-6.2'}, {'value': '-6.9', 'groupId': 'OG001', 'lowerLimit': '-8.3', 'upperLimit': '-5.5'}]}]}, {'title': 'Sleep Somnolence Score: Week 16', 'categories': [{'measurements': [{'value': '-9.8', 'groupId': 'OG000', 'lowerLimit': '-11.3', 'upperLimit': '-8.4'}, {'value': '-7.4', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '-6.0'}]}]}, {'title': 'Sleep Somnolence Score: Week 26', 'categories': [{'measurements': [{'value': '-9.9', 'groupId': 'OG000', 'lowerLimit': '-11.3', 'upperLimit': '-8.5'}, {'value': '-7.6', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '-6.2'}]}]}, {'title': 'Sleep Problems Index I Score: Week 12', 'categories': [{'measurements': [{'value': '-12.1', 'groupId': 'OG000', 'lowerLimit': '-13.4', 'upperLimit': '-10.8'}, {'value': '-10.9', 'groupId': 'OG001', 'lowerLimit': '-12.2', 'upperLimit': '-9.6'}]}]}, {'title': 'Sleep Problems Index I Score: Week 16', 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-14.5', 'upperLimit': '-12.0'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-12.2', 'upperLimit': '-9.8'}]}]}, {'title': 'Sleep Problems Index I Score: Week 26', 'categories': [{'measurements': [{'value': '-12.9', 'groupId': 'OG000', 'lowerLimit': '-14.2', 'upperLimit': '-11.7'}, {'value': '-12.1', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '-10.9'}]}]}, {'title': 'Sleep Problems Index II Score: Week 12', 'categories': [{'measurements': [{'value': '-14.4', 'groupId': 'OG000', 'lowerLimit': '-15.7', 'upperLimit': '-13.1'}, {'value': '-12.2', 'groupId': 'OG001', 'lowerLimit': '-13.5', 'upperLimit': '-10.9'}]}]}, {'title': 'Sleep Problems Index II Score: Week 16', 'categories': [{'measurements': [{'value': '-15.7', 'groupId': 'OG000', 'lowerLimit': '-17.0', 'upperLimit': '-14.4'}, {'value': '-12.8', 'groupId': 'OG001', 'lowerLimit': '-14.0', 'upperLimit': '-11.5'}]}]}, {'title': 'Sleep Problems Index II Score: Week 26', 'categories': [{'measurements': [{'value': '-15.4', 'groupId': 'OG000', 'lowerLimit': '-16.7', 'upperLimit': '-14.1'}, {'value': '-14.0', 'groupId': 'OG001', 'lowerLimit': '-15.2', 'upperLimit': '-12.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.6', 'estimateComment': 'Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.4', 'estimateComment': 'Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.4', 'estimateComment': 'Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.4', 'estimateComment': 'Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '2.2', 'estimateComment': 'Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.6', 'estimateComment': 'Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '0.5', 'estimateComment': 'Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.5', 'estimateComment': 'Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.4', 'estimateComment': 'Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '-1.6', 'estimateComment': 'Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-1.4', 'estimateComment': 'Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.7', 'estimateComment': 'Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '3.6', 'estimateComment': 'Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '0.4', 'ciUpperLimit': '5.4', 'estimateComment': 'Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '3.4', 'estimateComment': 'Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.3', 'estimateComment': 'Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '-0.4', 'estimateComment': 'Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '-0.3', 'estimateComment': 'Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.7', 'estimateComment': 'Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '-0.5', 'estimateComment': 'Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.9', 'estimateComment': 'Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '-0.3', 'estimateComment': 'Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '-1.1', 'estimateComment': 'Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '0.4', 'estimateComment': 'Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-3.7', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-3.4'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-2.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-4.2'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '-3.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-4.4', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-4.2'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '-4.0'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-4.5'}, {'value': '-4.5', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '-4.2'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '-4.3'}, {'value': '-4.3', 'groupId': 'OG001', 'lowerLimit': '-4.6', 'upperLimit': '-4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.8', 'estimateComment': 'Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.1', 'estimateComment': 'Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'estimateComment': 'Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.0', 'estimateComment': 'Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.1', 'estimateComment': 'Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 12, 16, 20 and 26', 'description': 'The skin pain NRS was a participant reported outcome where participants were asked to rate the "worst skin pain" in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Medicated Topical Background Therapy-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '56.8'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '27.9', 'upperLimit': '38.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '10.5', 'ciUpperLimit': '25.7', 'groupDescription': 'Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 up to Week 26', 'description': 'Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of all randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '77.2', 'upperLimit': '85.4'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '62.6', 'upperLimit': '72.4'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '89.2'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '85.5'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '86.8'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '88.1'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '85.9'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '79.8', 'upperLimit': '87.6'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '81.2'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '84.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '7.3', 'ciUpperLimit': '20.1', 'estimateComment': 'Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '9.4', 'estimateComment': 'Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '4.0', 'estimateComment': 'Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '3.6', 'estimateComment': 'Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '1.9', 'estimateComment': 'Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 12, 16, 20 and 26', 'description': 'DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Study Discontinuation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; a congenital anomaly/birth defect and other important medical events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'The pre-defined criteria for laboratory parameters included: hemoglobin (\\<9 grams per deciliter or decreases to \\>=2 below baseline); platelets (\\<75\\*10\\^3 cells per millimeter cube \\[mm\\^3\\]); lymphocytes (\\<0.5\\*10\\^3 cells per mm\\^3); neutrophils (\\<1\\*10\\^3 cells per mm\\^3); aspartate aminotransferase and alanine aminotransferase (\\>3\\* upper limit of normal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'Vital signs including temperature, systolic and diastolic blood pressure, and pulse rate were measured in a seated position after 5 minutes rest. Clinically significant change from baseline in vital signs were determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'FG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '365'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '334'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Medication Error Without Associated Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'This was a double-blind, double-dummy, active-controlled study in adult participants with moderate to severe atopic dermatitis. The study was conducted across 143 sites in 15 countries.', 'preAssignmentDetails': 'A total of 940 participants were screened, of which 213 were screen failures and were not enrolled. 727 participants were enrolled in the study and assigned to a study intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '727', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abrocitinib 200 mg QD', 'description': 'Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'BG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '35.5', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '668', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 3539815, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-09T08:42', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 7852273, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-09T08:42', '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': 727}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2020-03-27', 'resultsFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-09', 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; a congenital anomaly/birth defect and other important medical events.'}, {'measure': 'Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'The pre-defined criteria for laboratory parameters included: hemoglobin (\\<9 grams per deciliter or decreases to \\>=2 below baseline); platelets (\\<75\\*10\\^3 cells per millimeter cube \\[mm\\^3\\]); lymphocytes (\\<0.5\\*10\\^3 cells per mm\\^3); neutrophils (\\<1\\*10\\^3 cells per mm\\^3); aspartate aminotransferase and alanine aminotransferase (\\>3\\* upper limit of normal).'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'Vital signs including temperature, systolic and diastolic blood pressure, and pulse rate were measured in a seated position after 5 minutes rest. Clinically significant change from baseline in vital signs were determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data', 'timeFrame': 'From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)', 'description': 'A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2', 'timeFrame': 'Week 2', 'description': 'The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.'}, {'measure': 'Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4', 'timeFrame': 'Week 4', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving EASI-90 Response at Week 16', 'timeFrame': 'Week 16', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.'}, {'measure': 'Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26', 'timeFrame': 'Week 2, 8, 12, 20 and 26', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.'}, {'measure': 'Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20 and 26', 'description': 'EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.'}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26", 'timeFrame': 'Week 2, 4, 8, 12, 16, 20 and 26', 'description': 'IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.'}, {'measure': 'Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15', 'timeFrame': 'Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.'}, {'measure': 'Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26', 'timeFrame': 'Week 4, 8, 12, 16, 20 and 26', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.'}, {'measure': 'Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.'}, {'measure': 'Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26', 'description': "The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD."}, {'measure': 'Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26', 'description': "SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety.'}, {'measure': 'Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-D assessed the state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26', 'timeFrame': 'Baseline (Day 1), Week 2, 12, 16, 20 and 26', 'description': 'DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.'}, {'measure': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': "The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state."}, {'measure': 'Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.'}, {'measure': 'Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26', 'timeFrame': 'Baseline (Day 1), Week 12, 16 and 26', 'description': 'The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.'}, {'measure': 'Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26', 'timeFrame': 'Baseline (Day 1), Week 2, 12, 16, 20 and 26', 'description': 'The skin pain NRS was a participant reported outcome where participants were asked to rate the "worst skin pain" in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.'}, {'measure': 'Medicated Topical Background Therapy-free Days', 'timeFrame': 'Day 1 up to Week 26', 'description': 'Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.'}, {'measure': 'Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26', 'timeFrame': 'Week 2, 12, 16, 20 and 26', 'description': 'DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'atopic eczema', 'eczema', 'JAK', 'janus kinase'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '40987931', 'type': 'DERIVED', 'citation': 'Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23.'}, {'pmid': '39903335', 'type': 'DERIVED', 'citation': 'Silverberg JI, Simpson EL, Pink AE, Weidinger S, Chan G, Biswas P, Clibborn C, Guler E. Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE. Dermatol Ther (Heidelb). 2025 Feb;15(2):367-380. doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.'}, {'pmid': '37254941', 'type': 'DERIVED', 'citation': 'Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Comparing how well abrocitinib and dupilumab treat atopic dermatitis signs and symptoms: a plain language summary. Immunotherapy. 2023 Sep;15(13):975-980. doi: 10.2217/imt-2022-0306. Epub 2023 May 31.'}, {'pmid': '35871814', 'type': 'DERIVED', 'citation': 'Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022 Jul 23;400(10348):273-282. doi: 10.1016/S0140-6736(22)01199-0.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7451050', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosis of chronic atopic dermatitis (AD) for at least 6 months\n* Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)\n* Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease\n\nExclusion Criteria:\n\n* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation\n* Have increased risk of developing venous thromboembolism\n* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study\n* Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab\n* Other active non-AD inflammatory skin diseases or conditions affecting skin\n* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator\n* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception'}, 'identificationModule': {'nctId': 'NCT04345367', 'briefTitle': 'Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS', 'orgStudyIdInfo': {'id': 'B7451050'}, 'secondaryIdInfos': [{'id': '2019-004013-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abrocitinib 200 mg plus placebo injection', 'description': 'Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24', 'interventionNames': ['Drug: Abrocitinib 200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dupilumab 300 mg plus placebo tablets', 'description': 'Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26', 'interventionNames': ['Combination Product: Dupilumab 300 mg']}], 'interventions': [{'name': 'Abrocitinib 200 mg', 'type': 'DRUG', 'description': 'Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.', 'armGroupLabels': ['Abrocitinib 200 mg plus placebo injection']}, {'name': 'Dupilumab 300 mg', 'type': 'COMBINATION_PRODUCT', 'description': 'Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). 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