Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-29 @ 1:17 PM
Study NCT ID:
NCT05593432
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2022-10-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, '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': 'from Baseline to Week 32 plus 30 days', 'description': 'For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks in the Double-Blind, Vehicle-Controlled Period.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ruxolitinib Cream 1.5% BID', 'description': 'Participants who applied ruxolitinib cream 1.5% BID for 16 weeks during the Double-Blind, Vehicle-Controlled Period plus participants who completed the Week 16 assessments with no safety concerns, continued into the Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for an additional 16 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 14, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '68.1'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '40.0'}]}]}], 'analyses': [{'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.4', 'ciLowerLimit': '7.55', 'ciUpperLimit': '51.33', 'pValueComment': "stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)", 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.17', 'estimateComment': 'stratified by Baseline IGA score (3 or 4)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.04', 'ciLowerLimit': '1.32', 'ciUpperLimit': '12.38', 'estimateComment': 'stratified by Baseline IGA score (3 or 4)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 16', 'description': "The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might have taken during their participation in the Double-blind; vehicle-controlled (DBVC) period. Missing post-Baseline values were imputed as nonresponders. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '25.8'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '21.4'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '44.6'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '30.7'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': '69.8'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '29.8'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '71.7'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '43.5'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '71.7'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '43.5'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.6', 'ciLowerLimit': '7.71', 'ciUpperLimit': '53.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.68', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'stratified by Baseline IGA score (3 or 4)', 'nonInferiorityComment': 'A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.16', 'ciLowerLimit': '1.31', 'ciUpperLimit': '13.17', 'estimateComment': 'stratified by Baseline IGA score (3 or 4)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Extension Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'OG001', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'classes': [{'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '76.5'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '44.9'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '79.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '54.0'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '76.5'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '65.1'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '76.5'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '67.2'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '77.3'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '80.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '41.0'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '17.2'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '64.3'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '23.5'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '73.4'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '24.3'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '72.2'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '31.2'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '76.6'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '39.4'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.3', 'ciLowerLimit': '16.61', 'ciUpperLimit': '64.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'stratified by Baseline IGA score (3 or 4)', 'nonInferiorityComment': 'A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.67', 'ciLowerLimit': '1.85', 'ciUpperLimit': '24.02', 'estimateComment': 'stratified by Baseline IGA score (3 or 4)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Extension Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'OG001', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'classes': [{'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '89.3'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '68.7'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '89.8'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '82.8'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '57.8', 'upperLimit': '92.9'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '52.8', 'upperLimit': '91.8'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '97.1'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '93.2'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '96.6'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '92.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '27.0'}, {'value': '97.0', 'comment': 'The upper limit of the confidence interval was not estimable because there were too few events of ITCH4 response.', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.850', 'ciLowerLimit': '1.510', 'ciUpperLimit': '5.381', 'estimateComment': 'Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream', 'nonInferiorityComment': "A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties."}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Week 16', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '2.303', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '2.618', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': '2.047', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.975', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.64', 'spread': '2.307', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '1.261', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.96', 'spread': '2.622', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '1.385', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.01', 'spread': '2.823', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '1.613', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.02', 'spread': '2.656', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '2.263', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. No imputation was performed for missing values. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Extension Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'OG001', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '2.303', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '2.618', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.65', 'spread': '2.086', 'groupId': 'OG000'}, {'value': '-2.46', 'spread': '2.253', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '2.079', 'groupId': 'OG000'}, {'value': '-2.96', 'spread': '2.584', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.82', 'spread': '2.385', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '2.868', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.99', 'spread': '2.272', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '3.145', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.25', 'spread': '2.276', 'groupId': 'OG000'}, {'value': '-3.51', 'spread': '3.470', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Baseline to Week 16 plus 30 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who applied ruxolitinib 1.5% cream BID or vehicle cream BID at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Baseline to Week 16 plus 30 days', 'description': 'A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (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': 'Number of Participants With Any TEAE During the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Extension Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'OG001', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Week 17 to Week 32 plus 30 days', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Extension Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'OG001', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Week 17 to Week 32 plus 30 days', 'description': 'A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the 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': 'Open-label Extension Evaluable Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'FG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}, {'id': 'FG002', 'title': 'Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.'}, {'id': 'FG003', 'title': 'Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID', 'description': 'Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.'}], 'periods': [{'title': '16-Week DBVC Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '16-Week OLE Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'This study was conducted at 19 study centers in Canada and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID', 'description': 'Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.'}, {'id': 'BG001', 'title': 'Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID', 'description': 'Participants applied matching vehicle cream BID for 16 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '14.35', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '10.86', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '12.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Biracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-27', 'size': 838572, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-30T08:45', 'hasProtocol': True}, {'date': '2023-08-30', 'size': 519762, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-30T08:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study will include a 16 week double-blind period followed by a 16 week open-label period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03147742', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2022-10-21', 'resultsFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-30', 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16", 'timeFrame': 'Baseline; Week 16', 'description': "The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.'}, {'measure': 'Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.'}, {'measure': 'Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.'}, {'measure': 'Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.'}, {'measure': 'Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period', 'timeFrame': 'up to Week 16', 'description': 'ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.'}, {'measure': 'Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period', 'timeFrame': 'Baseline; Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period', 'timeFrame': 'Baseline; Weeks 18, 20, 24, 28, and 32', 'description': 'Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period', 'timeFrame': 'from Baseline to Week 16 plus 30 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.'}, {'measure': 'Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period', 'timeFrame': 'from Baseline to Week 16 plus 30 days', 'description': 'A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (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': 'Number of Participants With Any TEAE During the Open-label Extension Period', 'timeFrame': 'from Week 17 to Week 32 plus 30 days', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.'}, {'measure': 'Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period', 'timeFrame': 'from Week 17 to Week 32 plus 30 days', 'description': 'A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lichen Planus', 'Skin Diseases', '18424', 'Ruxolitinib', 'topical cream'], 'conditions': ['Cutaneous Lichen Planus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of LP with predominant cutaneous involvement.\n* IGA score of 3 or 4 at screening and baseline.\n* Baseline LP-related Itch NRS score ≥ 4.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Concurrent conditions and history of other diseases:\n\n 1. Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.\n 2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.\n 3. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.\n 4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).\n 5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.\n 6. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week before baseline.\n* Laboratory values outside of the protocol-defined criteria.\n* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.\n* Other exclusive criteria may apply."}, 'identificationModule': {'nctId': 'NCT05593432', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus', 'orgStudyIdInfo': {'id': 'INCB 18424-216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib cream', 'description': 'Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.', 'interventionNames': ['Drug: Ruxolitinib cream', 'Drug: Vehicle cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.', 'interventionNames': ['Drug: Vehicle cream']}], 'interventions': [{'name': 'Ruxolitinib cream', 'type': 'DRUG', 'otherNames': ['INCB018424 cream'], 'description': 'Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.', 'armGroupLabels': ['Ruxolitinib cream']}, {'name': 'Vehicle cream', 'type': 'DRUG', 'description': 'Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.', 'armGroupLabels': ['Ruxolitinib cream', 'Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Dermatology Specialists Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90056', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wallace of Beverly Hills', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore Medical Group Dermatology Skokie', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group Llc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delricht Clinical Research-Clinedge-Ppds Baton Rouge', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delricht Research - Touro Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dermassociates', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Jdr Dermatology Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'OPTISKIN', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bexley Dermatology', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinohio Research Services', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Clinical Research Center', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Central Sooner Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104-5160', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania-Perelman School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37130-2450', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'International Clinical Research Ic Research Murfreesboro', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'zip': '76011-3800', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center For Dermatology', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Institute For Clinical Research Aicr Pflugerville', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Care Midvalley Health Center Dermatology', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Wiseman Dermatology Research Inc', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. S. K. Siddha Medicine Professional Corporation', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}], 'overallOfficials': [{'name': 'Haq Nawaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'url': 'https://www.incyte.com/our-company/compliance-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.', 'ipdSharing': 'YES', 'description': 'Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThe trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency', 'accessCriteria': 'Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}