Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04921969
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2021-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Italy', 'Poland', 'Spain', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 60 weeks', 'description': 'Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 up to Week 8.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 4, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 50, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 49, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 47, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eczema herpeticum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '20.9'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '45.3'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '47.6', 'upperLimit': '65.1'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.74', 'ciLowerLimit': '1.951', 'ciUpperLimit': '13.315', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.72', 'ciLowerLimit': '4.429', 'ciUpperLimit': '30.042', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups for this population were defined according to the treatment assignment at the time of randomization.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '15.873', 'upperLimit': '46.980'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '26.919', 'upperLimit': '49.035'}, {'value': '43.4', 'groupId': 'OG002', 'lowerLimit': '32.083', 'upperLimit': '55.288'}]}]}], 'analyses': [{'pValue': '0.4198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.610', 'ciUpperLimit': '3.268', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1685', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '0.779', 'ciUpperLimit': '4.174', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 7 (Week 1)', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 7 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 3', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 3 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators.'}, {'type': 'SECONDARY', 'title': 'VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Baseline up to Week 8', 'description': 'An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all randomized participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Number of Participants With Any TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 8 up to Week 56', 'description': 'An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS Evaluable Population: all participants who applied study drug at least once during the LTS Period'}, {'type': 'SECONDARY', 'title': 'VC Period: Number of Participants With Any Grade 3 or Higher TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Baseline up to Week 8', 'description': 'A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'LTS Period: Number of Participants With Any Grade 3 or Higher TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 12 up to Week 56', 'description': 'A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS Evaluable Population'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '32.8'}, {'value': '35.1', 'groupId': 'OG002', 'lowerLimit': '27.0', 'upperLimit': '43.9'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '22.8'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '45.3'}, {'value': '48.1', 'groupId': 'OG002', 'lowerLimit': '39.3', 'upperLimit': '57.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '1.704', 'upperLimit': '21.910'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '14.945', 'upperLimit': '34.578'}, {'value': '23.7', 'groupId': 'OG002', 'lowerLimit': '14.682', 'upperLimit': '34.824'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '3.025', 'upperLimit': '25.418'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '23.553', 'upperLimit': '45.191'}, {'value': '36.8', 'groupId': 'OG002', 'lowerLimit': '26.058', 'upperLimit': '48.686'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '1.702', 'upperLimit': '15.013'}, {'value': '35.8', 'groupId': 'OG001', 'lowerLimit': '27.728', 'upperLimit': '44.556'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '34.876', 'upperLimit': '52.447'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '5.466', 'upperLimit': '22.819'}, {'value': '53.0', 'groupId': 'OG001', 'lowerLimit': '44.178', 'upperLimit': '61.658'}, {'value': '62.6', 'groupId': 'OG002', 'lowerLimit': '53.718', 'upperLimit': '70.890'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '7.632', 'upperLimit': '26.478'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '42.708', 'upperLimit': '60.210'}, {'value': '67.2', 'groupId': 'OG002', 'lowerLimit': '58.432', 'upperLimit': '75.123'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2, 4, and 8', 'description': 'The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of ≥8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l), each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata 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. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Improvement of at least 2 points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '21.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '6.0'}]}]}, {'title': 'Improvement of at least 4 points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'comment': 'The upper limit of the 95% confidence interval was not estimable because there were too few participants with events.', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': 'NA'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '20.0'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked 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. Kaplan-Meier estimation method was used for analyses.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants who were at least 6 years of age and had a Baseline Itch NRS score ≥2 (for assessment of improvement of at least 2 points) or ≥4 (for assessment of improvement of at least 4 points), a daily Itch NRS assessment during the VC Period, and available data were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG003', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG004', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG005', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG006', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'periods': [{'title': 'VC Period (Day 1 to Week 8)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '131'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', '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'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', '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'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol-specified Withdrawal Criterion Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'LTS Period (Weeks 8 to 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '119'}, {'groupId': 'FG006', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '71'}, {'groupId': 'FG006', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '48'}, {'groupId': 'FG006', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '18'}]}, {'type': 'Protocol-specified Withdrawal Criterion Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Follow-up Not Performed per Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 330 participants were enrolled at 48 study centers in the United States and Canada.', 'preAssignmentDetails': 'Participants who completed Week 8 assessments of the Vehicle-controlled (VC) Period with no safety concerns continued in the 44-week Long-term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period, and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups (ruxolitinib 0.75%, ruxolitinib 1.5%) cream during the LTS Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '2.83', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '2.94', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '2.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'American-Indian/Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American and White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Mixed, Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Captured as Hispanic or Latino in Database', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian and North African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Caregiver Did Not Identify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rican', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black and Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'African-American/Black, Hispanic, and Caucasian/White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Portuguese', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Brazilian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-23', 'size': 1860391, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-08T08:53', 'hasProtocol': True}, {'date': '2023-06-02', 'size': 771198, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-08T08:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2021-06-07', 'resultsFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-07', 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8", 'timeFrame': 'Baseline to Week 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.'}], 'secondaryOutcomes': [{'measure': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)', 'timeFrame': 'Baseline to Day 7 (Week 1)', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3', 'timeFrame': 'Baseline to Day 3', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'from Baseline up to Week 8', 'description': 'An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.'}, {'measure': 'LTS Period: Number of Participants With Any TEAE', 'timeFrame': 'From Week 8 up to Week 56', 'description': 'An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.'}, {'measure': 'VC Period: Number of Participants With Any Grade 3 or Higher TEAE', 'timeFrame': 'from Baseline up to Week 8', 'description': 'A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.'}, {'measure': 'LTS Period: Number of Participants With Any Grade 3 or Higher TEAE', 'timeFrame': 'From Week 12 up to Week 56', 'description': 'A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.'}, {'measure': 'VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8', 'timeFrame': 'Baseline to Weeks 2, 4, and 8', 'description': 'The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of ≥8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l), each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata 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. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.'}, {'measure': 'VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points', 'timeFrame': 'up to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked 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. Kaplan-Meier estimation method was used for analyses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Ruxolitinib'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 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 AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).\n* Participants with IGA score of 2 to 3 at the screening and baseline visits.\n* Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.\n* For children aged 6 years to \\< 12 years, baseline itch NRS score ≥ 4.\n* Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.\n* Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant\'s disease state but not located on the hands, feet, or genitalia.\n* Willingness to avoid pregnancy or fathering a child for the duration of study participation.\n\nExclusion Criteria:\n\n* An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.\n* Concurrent conditions and history of other diseases as follows:\n\n 1. Immunocompromised\n 2. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.\n 3. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.\n 4. Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.\n 5. Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.\n 6. Other types of eczema.\n 7. Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.\n* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator\'s opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Use of any of the following treatments within the indicated washout period before the baseline visit:\n\n 1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).\n 2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).\n 3. 2 weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.\n 4. 1 week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week.\n* Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant\'s AD.-\n* Positive serology test results at screening for HIV antibody.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.\n* In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.\n* Employees of the sponsor or investigator or otherwise dependents of them.'}, 'identificationModule': {'nctId': 'NCT04921969', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)', 'orgStudyIdInfo': {'id': 'INCB 18424-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib (1.5% Cream)', 'description': 'Study drug will be administered twice daiily.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib (0.75% cream)', 'description': 'Study drug will be administered twice daily.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Vehicle cream will be administered twice daily.', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi'], 'description': 'The study cream will be applied topically twice a day for up to 52 weeks.', 'armGroupLabels': ['Ruxolitinib (0.75% cream)', 'Ruxolitinib (1.5% Cream)']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching vehicle cream will be applied topically twice a day for up to 8 weeks.', 'armGroupLabels': ['Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85295', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Physicians Research Group Ii', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cct Research With Center For Dermatology and Plastic Surgery', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'First Oc Dermatology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Iact Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Metropolis Dermatology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93637', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': 'Madera Family Medical Group', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Associates of Southern California', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research-Clinedge-Ppds', 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