Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT03011892
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Clinical Study Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 24', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 3, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'INCB018424 0.15% QD', 'description': 'Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 6, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'INCB018424 0.5% QD', 'description': 'Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 2, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'INCB018424 1.5% QD', 'description': 'Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 6, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'INCB018424 1.5% BID', 'description': 'Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 23, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 259, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 259, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.90', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '-71.57', 'spread': '6.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square (LS) Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.66', 'ciLowerLimit': '-77.85', 'ciUpperLimit': '-41.47', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID or ruxolitinib 1.5% BID, with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.90', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '-44.92', 'spread': '6.47', 'groupId': 'OG001'}, {'value': '-52.80', 'spread': '6.52', 'groupId': 'OG002'}, {'value': '-66.72', 'spread': '6.36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.01', 'ciLowerLimit': '-51.27', 'ciUpperLimit': '-14.76', 'groupDescription': 'DB: Vehicle BID, Ruxolitinib 0.15% QD', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.90', 'ciLowerLimit': '-59.23', 'ciUpperLimit': '-22.57', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.82', 'ciLowerLimit': '-72.93', 'ciUpperLimit': '-36.70', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD in the DB Period, with available data were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.54', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '-44.92', 'spread': '6.47', 'groupId': 'OG001'}, {'value': '-52.80', 'spread': '6.52', 'groupId': 'OG002'}, {'value': '-66.72', 'spread': '6.36', 'groupId': 'OG003'}, {'value': '-71.57', 'spread': '6.42', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.63', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '32.73', 'groupDescription': 'Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4659', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.74', 'ciLowerLimit': '-11.44', 'ciUpperLimit': '24.92', 'groupDescription': 'Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4320', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.18', 'ciLowerLimit': '-25.13', 'ciUpperLimit': '10.77', 'groupDescription': 'Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1903', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.02', 'ciLowerLimit': '-30.05', 'ciUpperLimit': '6.00', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from ITT population, all participants who are randomized to TAC 0.1% BID followed by vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD/BID in the DB Period, with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '5.34', 'groupId': 'OG000'}, {'value': '-39.94', 'spread': '5.29', 'groupId': 'OG001'}, {'value': '-29.96', 'spread': '5.23', 'groupId': 'OG002'}, {'value': '-45.88', 'spread': '5.41', 'groupId': 'OG003'}, {'value': '-49.88', 'spread': '5.18', 'groupId': 'OG004'}, {'value': '-52.68', 'spread': '5.29', 'groupId': 'OG005'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-21.86', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '-58.02', 'spread': '6.94', 'groupId': 'OG001'}, {'value': '-50.24', 'spread': '6.82', 'groupId': 'OG002'}, {'value': '-58.37', 'spread': '6.93', 'groupId': 'OG003'}, {'value': '-67.05', 'spread': '6.72', 'groupId': 'OG004'}, {'value': '-79.01', 'spread': '6.83', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.12', 'ciLowerLimit': '-39.84', 'ciUpperLimit': '-10.41', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.85', 'ciLowerLimit': '-62.64', 'ciUpperLimit': '-33.06', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.04', 'ciLowerLimit': '-56.00', 'ciUpperLimit': '-26.08', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.05', 'ciLowerLimit': '-59.69', 'ciUpperLimit': '-30.40', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1806', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.99', 'ciLowerLimit': '-4.66', 'ciUpperLimit': '24.63', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4333', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.93', 'ciLowerLimit': '-20.82', 'ciUpperLimit': '8.95', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1805', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.94', 'ciLowerLimit': '-24.51', 'ciUpperLimit': '4.63', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0895', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.74', 'ciLowerLimit': '-27.45', 'ciUpperLimit': '1.98', 'groupDescription': 'Week 2', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.38', 'ciLowerLimit': '-47.74', 'ciUpperLimit': '-9.02', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.52', 'ciLowerLimit': '-56.03', 'ciUpperLimit': '-17.01', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.19', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.15', 'ciLowerLimit': '-76.53', 'ciUpperLimit': '-37.77', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4243', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.78', 'ciLowerLimit': '-11.37', 'ciUpperLimit': '26.93', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9715', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-19.65', 'ciUpperLimit': '18.95', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3507', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.03', 'ciLowerLimit': '-28.05', 'ciUpperLimit': '9.99', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0320', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.98', 'ciLowerLimit': '-40.15', 'ciUpperLimit': '-1.82', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2 and 8', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who are randomized to Vehicle BID, TAC 0.1% BID/Vehicle Cream BID, Ruxolitinib 0.15%, 0.5%, 1.5%, 1.5% QD/BID in the DB Period. The overall number of participants analyzed are participants with data available for analysis for this Outcome Measure and "n" signifies number of participants with data available at specific timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}, {'value': '31.4', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '52.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '52.9', 'groupId': 'OG002'}, {'value': '58.8', 'groupId': 'OG003'}, {'value': '73.1', 'groupId': 'OG004'}, {'value': '78.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '60.8', 'groupId': 'OG001'}, {'value': '54.9', 'groupId': 'OG002'}, {'value': '62.7', 'groupId': 'OG003'}, {'value': '69.2', 'groupId': 'OG004'}, {'value': '76.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4 and 8', 'description': 'The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who are randomized to the study.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in EASI Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.5', 'spread': '65.71', 'groupId': 'OG000'}, {'value': '-59.8', 'spread': '35.71', 'groupId': 'OG001'}, {'value': '-45.4', 'spread': '53.96', 'groupId': 'OG002'}, {'value': '-52.2', 'spread': '48.32', 'groupId': 'OG003'}, {'value': '-67.0', 'spread': '26.28', 'groupId': 'OG004'}, {'value': '-71.6', 'spread': '25.27', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at Week 4.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve EASI-50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 8', 'description': 'Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.', 'unitOfMeasure': 'week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who are randomized to the study.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}, {'value': '13.5', 'groupId': 'OG004'}, {'value': '8.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '13.7', 'groupId': 'OG003'}, {'value': '21.2', 'groupId': 'OG004'}, {'value': '38.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '15.7', 'groupId': 'OG002'}, {'value': '31.4', 'groupId': 'OG003'}, {'value': '30.8', 'groupId': 'OG004'}, {'value': '48.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4 and 8', 'description': 'IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who are randomized to the study.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/ Vehicle BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '1.71', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '2.14', 'groupId': 'OG004'}, {'value': '5.9', 'spread': '2.25', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '2.23', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '2.14', 'groupId': 'OG004'}, {'value': '-3.7', 'spread': '2.56', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '2.22', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '2.24', 'groupId': 'OG004'}, {'value': '-4.0', 'spread': '2.89', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '2.41', 'groupId': 'OG003'}, {'value': '-3.8', 'spread': '2.39', 'groupId': 'OG004'}, {'value': '-4.2', 'spread': '2.91', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4 and 8', 'description': 'The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at specified time-point and 'n' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least One Adverse Event (AEs) and as Per Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '45', 'groupId': 'OG008'}, {'value': '41', 'groupId': 'OG009'}, {'value': '42', 'groupId': 'OG010'}, {'value': '43', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Vehicle BID', 'description': 'Participants applied vehicle cream BID for 8 weeks in DB period.'}, {'id': 'OG001', 'title': 'DB: TAC 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'OG002', 'title': 'DB: Ruxolitinib 0.15% QD', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'OG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'OG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}, {'id': 'OG006', 'title': 'OL: Vehicle BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks'}, {'id': 'OG007', 'title': 'OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'OG008', 'title': 'OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'OG009', 'title': 'OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'OG010', 'title': 'OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'OG011', 'title': 'OL: Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}], 'classes': [{'title': 'At Least One AE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 and Higher', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population in the DB treatment period included all enrolled participants who applied at least 1 dose of ruxolitinib cream, triamcinolone cream, or vehicle cream.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double Blind (DB): Vehicle BID', 'description': 'Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.'}, {'id': 'FG001', 'title': 'DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'FG002', 'title': 'DB: Ruxolitinib 0.15% Once Daily (QD)', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'FG003', 'title': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'FG004', 'title': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'FG005', 'title': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}, {'id': 'FG006', 'title': 'Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'FG007', 'title': 'OL: TAC BID/ Vehicle BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'FG008', 'title': 'OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'FG009', 'title': 'OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'FG010', 'title': 'OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}, {'id': 'FG011', 'title': 'OL: Ruxolitinib 1.5% Cream BID for 8 Weeks in DB Period.', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.'}], 'periods': [{'title': 'Double Blind (DB) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '50'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Treated in DB Period', 'comment': 'One participant was randomized but did not receive study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '50'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Completed Treatment Through Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed= Number of participants who completed treatment through Week 8 in DB period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '45'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Open Label (OL) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '41'}, {'groupId': 'FG007', 'numSubjects': '40'}, {'groupId': 'FG008', 'numSubjects': '45'}, {'groupId': 'FG009', 'numSubjects': '41'}, {'groupId': 'FG010', 'numSubjects': '42'}, {'groupId': 'FG011', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '34'}, {'groupId': 'FG007', 'numSubjects': '37'}, {'groupId': 'FG008', 'numSubjects': '43'}, {'groupId': 'FG009', 'numSubjects': '41'}, {'groupId': 'FG010', 'numSubjects': '40'}, {'groupId': 'FG011', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 307 participants were randomized and 306 were treated at 50 study centers in the United States and Canada from 9 January 2017 to 12 March 2018.', 'preAssignmentDetails': '307 participants randomized to 6 treatment groups (ruxolitinib cream 1.5% BID, or QD, 0.5% or 0.15% QD, vehicle BID, \\& TAC 0.1% BID). Participants applied blinded study drug for 8 weeks, TAC 0.1% BID for 4 weeks followed by vehicle BID for 4 weeks in DB period. After DB period, participants who met criteria (compliant with the protocol and no safety concerns) offered OL treatment with ruxolitinib 1.5% BID for 4 weeks. Out of 261 participants who completed DB Period, 252 entered the OL Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '307', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Double Blind (DB): Vehicle BID', 'description': 'Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.'}, {'id': 'BG001', 'title': 'DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.'}, {'id': 'BG002', 'title': 'DB: Ruxolitinib 0.15% Once Daily (QD)', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.'}, {'id': 'BG003', 'title': 'DB : Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.'}, {'id': 'BG004', 'title': 'DB : Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.'}, {'id': 'BG005', 'title': 'DB : Ruxolitinib 1.5% Cream Twice Daily (BID)', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '15.04', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '16.19', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '13.83', 'groupId': 'BG002'}, {'value': '38.6', 'spread': '13.73', 'groupId': 'BG003'}, {'value': '39.1', 'spread': '14.54', 'groupId': 'BG004'}, {'value': '39.0', 'spread': '15.72', 'groupId': 'BG005'}, {'value': '38.1', 'spread': '14.82', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '139', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '285', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '172', 'groupId': 'BG006'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all participants who are randomized to the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-15', 'size': 950480, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-25T09:25', 'hasProtocol': True}, {'date': '2017-04-27', 'size': 579843, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-25T09:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2019-01-25', 'completionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2017-01-03', 'dispFirstSubmitQcDate': '2019-01-25', 'resultsFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2017-01-03', 'dispFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-16', 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.'}], 'secondaryOutcomes': [{'measure': 'Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.'}, {'measure': 'Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.'}, {'measure': 'Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8', 'timeFrame': 'Baseline, Week 2 and 8', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.'}, {'measure': 'Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8', 'timeFrame': 'Week 2, 4 and 8', 'description': 'The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).'}, {'measure': 'Percentage Change From Baseline in EASI Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.'}, {'measure': 'Time to Achieve EASI-50', 'timeFrame': 'From Baseline to Week 8', 'description': 'Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.'}, {'measure': "Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8", 'timeFrame': 'Week 2, 4 and 8', 'description': 'IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.'}, {'measure': 'Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8', 'timeFrame': 'Baseline, Week 2, 4 and 8', 'description': 'The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.'}, {'measure': 'Number of Participants With At Least One Adverse Event (AEs) and as Per Severity', 'timeFrame': 'Up to Week 24', 'description': 'AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'eczema', 'pruritus', 'Janus kinase (JAK) inhibitors'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '33982267', 'type': 'DERIVED', 'citation': 'Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.'}, {'pmid': '31629805', 'type': 'DERIVED', 'citation': 'Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.\n* Participants with a history of AD for at least 2 years.\n* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.\n* Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.\n* Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.\n\nExclusion Criteria:\n\n* Participants with evidence of active acute or chronic infections.\n* Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.\n* Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).\n* Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).\n* Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.\n* Participants with cytopenias at screening, defined as:\n\n * Leukocytes \\< 3.0 × 10\\^9/L.\n * Neutrophils \\< lower limit of normal.\n * Hemoglobin \\< 10 g/dL.\n * Lymphocytes \\< 0.8 × 10\\^9/L\n * Platelets \\< 100 × 10\\^9/L.\n* Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:\n\n * Serum creatinine \\> 1.5 mg/dL.\n * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.\n* Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).\n* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib)."}, 'identificationModule': {'nctId': 'NCT03011892', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'INCB 18424-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Double Blind (DB): Vehicle BID', 'description': 'Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.', 'interventionNames': ['Drug: Vehicle Cream BID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID', 'description': 'Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.', 'interventionNames': ['Drug: Triamcinolone 0.1% Cream BID', 'Drug: Vehicle Cream BID']}, {'type': 'EXPERIMENTAL', 'label': 'DB: Ruxolitinib 0.15% Once Daily (QD)', 'description': 'Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.', 'interventionNames': ['Drug: Ruxolitinib 0.15% Cream QD']}, {'type': 'EXPERIMENTAL', 'label': 'DB: Ruxolitinib 0.5% QD', 'description': 'Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.', 'interventionNames': ['Drug: Ruxolitinib 0.5% Cream QD']}, {'type': 'EXPERIMENTAL', 'label': 'DB: Ruxolitinib 1.5% QD', 'description': 'Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream QD']}, {'type': 'EXPERIMENTAL', 'label': 'DB: Ruxolitinib 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'EXPERIMENTAL', 'label': 'OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'EXPERIMENTAL', 'label': 'OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'EXPERIMENTAL', 'label': 'OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}, {'type': 'EXPERIMENTAL', 'label': 'OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID', 'description': 'Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.', 'interventionNames': ['Drug: Ruxolitinib 1.5% Cream BID']}], 'interventions': [{'name': 'Ruxolitinib 0.15% Cream QD', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib 0.15% cream QD', 'armGroupLabels': ['DB: Ruxolitinib 0.15% Once Daily (QD)']}, {'name': 'Ruxolitinib 0.5% Cream QD', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib 0.5% cream QD', 'armGroupLabels': ['DB: Ruxolitinib 0.5% QD']}, {'name': 'Ruxolitinib 1.5% Cream QD', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib 1.5% cream QD', 'armGroupLabels': ['DB: Ruxolitinib 1.5% QD']}, {'name': 'Ruxolitinib 1.5% Cream BID', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib 1.5% cream BID', 'armGroupLabels': ['DB: Ruxolitinib 1.5% BID', 'OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID', 'OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID', 'OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID', 'OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID', 'OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID', 'Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID']}, {'name': 'Triamcinolone 0.1% Cream BID', 'type': 'DRUG', 'description': 'Triamcinolone 0.1% cream BID', 'armGroupLabels': ['DB: 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