Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT05764161
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011536', 'term': 'Prurigo'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue 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 Week 56', 'description': 'For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Cream BID', 'description': 'Participants applied vehicle cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 4, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion for 12 weeks in the DBVC Period and for 40 weeks in the OLE Period. Participants who applied matching vehicle cream BID for 12 weeks during the DBVC Period and completed the Week 12 assessments with no safety concerns applied ruxolitinib 1.5% cream for 40 weeks during the OLE Period.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 19, 'seriousNumAtRisk': 178, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'WI-NRS4 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '46.7'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '50.6'}]}]}], 'analyses': [{'pValue': '0.5859', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.651', 'ciUpperLimit': '2.143', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.81', 'ciLowerLimit': '-9.84', 'ciUpperLimit': '17.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.966', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 12', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.', '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 cream the participant might have applied during their participation in the double-blind, vehicle-controlled period. Participants with a baseline ITCH Score ≥4 were analyzed.'}, {'type': 'SECONDARY', 'title': 'WI-NRS4 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '28.6'}, {'value': '30.5', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '40.8'}]}]}], 'analyses': [{'pValue': '0.0741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '0.938', 'ciUpperLimit': '3.683', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.15', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '23.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.162', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 4', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Participants with missing Week 4 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall-Treatment Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '13.4'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '20.8'}]}]}], 'analyses': [{'pValue': '0.1493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '0.750', 'ciUpperLimit': '5.740', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.17', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '14.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.257', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 12', 'description': "Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\]).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With IGA-CPG-S-TS at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '18.7'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '33.7'}]}]}], 'analyses': [{'pValue': '0.0142', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '1.193', 'ciUpperLimit': '6.033', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.46', 'ciLowerLimit': '2.90', 'ciUpperLimit': '24.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.384', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 12', 'description': 'IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.'}, {'type': 'SECONDARY', 'title': 'WI-NRS4 Response at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '12.4'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '24.7'}]}]}], 'analyses': [{'pValue': '0.0387', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.07', 'ciLowerLimit': '1.060', 'ciUpperLimit': '8.897', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.49', 'ciLowerLimit': '0.98', 'ciUpperLimit': '18.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.343', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Day 7', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'WI-NRS4 Response at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '11.2'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '25.2'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '31.4'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '42.9'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '42.9'}, {'value': '45.1', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '56.5'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '54.7'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '36.2', 'upperLimit': '59.0'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '66.2'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '61.4'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '80.1'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '45.6', 'upperLimit': '71.0'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '59.1', 'upperLimit': '83.3'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '47.4', 'upperLimit': '73.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '85.4'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '80.1'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '92.4'}, {'value': '71.7', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '84.0'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '93.2'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '50.7', 'upperLimit': '83.1'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '92.0'}, {'value': '76.0', 'groupId': 'OG001', 'lowerLimit': '54.9', 'upperLimit': '90.6'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '89.3'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '89.0'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '85.4'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '92.7'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '86.7'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '57.2', 'upperLimit': '98.2'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '89.7'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 52', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '-2.01', 'spread': '0.172', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.86', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '0.212', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-3.68', 'spread': '0.257', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.06', 'spread': '0.282', 'groupId': 'OG000'}, {'value': '-3.94', 'spread': '0.278', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '-0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.303', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.367', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.0287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.396', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.07', 'spread': '2.434', 'groupId': 'OG000'}, {'value': '-4.20', 'spread': '2.440', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.82', 'spread': '2.408', 'groupId': 'OG000'}, {'value': '-4.40', 'spread': '2.336', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'spread': '2.552', 'groupId': 'OG000'}, {'value': '-4.67', 'spread': '2.399', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.42', 'spread': '2.357', 'groupId': 'OG000'}, {'value': '-5.00', 'spread': '2.393', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.83', 'spread': '2.181', 'groupId': 'OG000'}, {'value': '-5.17', 'spread': '2.647', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.83', 'spread': '2.002', 'groupId': 'OG000'}, {'value': '-5.15', 'spread': '2.329', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.73', 'spread': '2.122', 'groupId': 'OG000'}, {'value': '-5.56', 'spread': '2.176', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.62', 'spread': '2.709', 'groupId': 'OG000'}, {'value': '-4.72', 'spread': '2.328', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.54', 'spread': '2.603', 'groupId': 'OG000'}, {'value': '-5.27', 'spread': '2.449', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.39', 'spread': '2.756', 'groupId': 'OG000'}, {'value': '-6.02', 'spread': '1.862', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '2.677', 'groupId': 'OG000'}, {'value': '-6.06', 'spread': '2.037', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Population: all participants who applied ruxolitinib 1.5% cream at least once during the OLE Period. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to ≥2-point Improvement From Baseline in WI-NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '30.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.783', 'ciLowerLimit': '1.288', 'ciUpperLimit': '2.468', 'estimateComment': 'Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Log-rank test stratified by randomization stratification factors between treatment and vehicle.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to ≥4-point Improvement From Baseline in WI-NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had events.', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': 'NA'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '53.0'}]}]}], 'analyses': [{'pValue': '0.0399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.477', 'ciLowerLimit': '1.015', 'ciUpperLimit': '2.150', 'estimateComment': 'Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Log-rank test stratified by randomization stratification factors between treatment and vehicle.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '32.7'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '51.2'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '46.2'}, {'value': '58.6', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '69.1'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '36.7', 'upperLimit': '59.6'}, {'value': '65.8', 'groupId': 'OG001', 'lowerLimit': '54.3', 'upperLimit': '76.1'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '71.6'}, {'value': '73.1', 'groupId': 'OG001', 'lowerLimit': '61.8', 'upperLimit': '82.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 12', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '82.1'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '68.3', 'upperLimit': '88.4'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '86.5'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '95.3'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '93.5'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '92.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '93.8'}, {'value': '89.4', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '96.5'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '78.3', 'upperLimit': '97.5'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '93.4'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '95.8'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '75.7', 'upperLimit': '98.1'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '95.6'}, {'value': '95.8', 'groupId': 'OG001', 'lowerLimit': '78.9', 'upperLimit': '99.9'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '93.9'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '59.5', 'upperLimit': '98.3'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '96.4'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '99.8'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '95.7'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '100.0'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '95.3'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 52', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '0.176', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.80', 'spread': '0.229', 'groupId': 'OG000'}, {'value': '-2.68', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.39', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '0.260', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.97', 'spread': '0.286', 'groupId': 'OG000'}, {'value': '-3.57', 'spread': '0.284', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.0071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.320', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.0198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.369', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.1384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.403', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 12', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '2.599', 'groupId': 'OG000'}, {'value': '-3.93', 'spread': '2.436', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.57', 'spread': '2.690', 'groupId': 'OG000'}, {'value': '-4.17', 'spread': '2.340', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.95', 'spread': '2.864', 'groupId': 'OG000'}, {'value': '-4.38', 'spread': '2.449', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.16', 'spread': '2.818', 'groupId': 'OG000'}, {'value': '-4.58', 'spread': '2.582', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.46', 'spread': '2.754', 'groupId': 'OG000'}, {'value': '-4.63', 'spread': '2.630', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.40', 'spread': '2.641', 'groupId': 'OG000'}, {'value': '-4.80', 'spread': '2.409', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.03', 'spread': '2.869', 'groupId': 'OG000'}, {'value': '-5.18', 'spread': '2.369', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.55', 'spread': '3.365', 'groupId': 'OG000'}, {'value': '-4.24', 'spread': '2.341', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.53', 'spread': '3.229', 'groupId': 'OG000'}, {'value': '-4.46', 'spread': '2.497', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'spread': '3.420', 'groupId': 'OG000'}, {'value': '-5.17', 'spread': '2.175', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.85', 'spread': '3.168', 'groupId': 'OG000'}, {'value': '-5.46', 'spread': '2.074', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'OLE Period: Change from baseline in Skin Pain NRS score at each post-baseline visit', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '11.1'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '9.2'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '12.6'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '20.2'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '18.9'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '33.2'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '21.0'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '38.6'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '34.8'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '43.4'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '40.1'}, {'value': '29.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '42.4'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '42.6'}, {'value': '27.1', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '40.3'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '45.1'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '46.3'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '54.7'}, {'value': '42.6', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '57.8'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '50.9'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '60.4'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '57.8'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '27.5', 'upperLimit': '66.1'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '65.5'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '72.2'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '70.2'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '72.2'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '69.2'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '73.4'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '72.2'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '31.6', 'upperLimit': '86.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 52', 'description': 'IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\]). Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.', '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 a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '11.1'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '17.8'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '16.9'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '25.2'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '27.1'}, {'value': '26.4', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '37.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '26.7'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '43.7'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '43.3'}, {'value': '41.1', 'groupId': 'OG001', 'lowerLimit': '29.7', 'upperLimit': '53.2'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '55.3'}, {'value': '45.3', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '58.3'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '39.3', 'upperLimit': '65.4'}, {'value': '49.2', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '62.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '67.8'}, {'value': '54.7', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '68.4'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '43.2', 'upperLimit': '72.4'}, {'value': '63.8', 'groupId': 'OG001', 'lowerLimit': '48.5', 'upperLimit': '77.3'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '68.8'}, {'value': '64.1', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '78.8'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '78.2'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '84.1'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '26.8', 'upperLimit': '69.4'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '72.2'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '70.2'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '72.2'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '69.2'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '67.7'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '77.0'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '80.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \\[up to approximately 10% of all pruriginous lesions\\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \\[approximately 11%-25% of all pruriginous lesions\\]); 3, moderate (many pruriginous lesions have excoriations or crusts \\[approximately 26%-75% of all pruriginous lesions\\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \\[approximately 76%-100% of all pruriginous lesions\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '16.9'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '20.4'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '26.3'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '31.2'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '31.0'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '50.1'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '42.4'}, {'value': '42.2', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '53.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '48.7'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '60.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '53.9'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '35.8', 'upperLimit': '61.3'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '57.6'}, {'value': '52.5', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '65.7'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '54.9'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '70.2'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '64.8'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '69.8'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '62.3'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '67.6'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '66.9'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '72.5'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '47.1', 'upperLimit': '86.8'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '85.8'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '74.3'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '85.8'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '74.0'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '83.7'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '77.0'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '31.6', 'upperLimit': '86.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '0.528', 'groupId': 'OG000'}, {'value': '-5.14', 'spread': '0.524', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '-5.93', 'spread': '0.570', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.43', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '-6.29', 'spread': '0.634', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.72', 'spread': '0.668', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '0.665', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.33', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.744', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.1447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.809', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.3395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-2.64', 'ciUpperLimit': '0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.900', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.4794', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '1.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.943', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.88', 'spread': '5.733', 'groupId': 'OG000'}, {'value': '-7.14', 'spread': '5.834', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.07', 'spread': '6.327', 'groupId': 'OG000'}, {'value': '-7.22', 'spread': '5.774', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.63', 'spread': '6.365', 'groupId': 'OG000'}, {'value': '-7.09', 'spread': '6.062', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.54', 'spread': '5.952', 'groupId': 'OG000'}, {'value': '-7.70', 'spread': '5.944', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.23', 'spread': '6.502', 'groupId': 'OG000'}, {'value': '-7.72', 'spread': '6.678', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '6.888', 'groupId': 'OG000'}, {'value': '-8.15', 'spread': '5.475', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.10', 'spread': '8.332', 'groupId': 'OG000'}, {'value': '-8.93', 'spread': '5.875', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.17', 'spread': '7.315', 'groupId': 'OG000'}, {'value': '-7.76', 'spread': '4.161', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.29', 'spread': '7.491', 'groupId': 'OG000'}, {'value': '-8.47', 'spread': '4.346', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.83', 'spread': '8.319', 'groupId': 'OG000'}, {'value': '-8.60', 'spread': '4.239', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.47', 'spread': '8.776', 'groupId': 'OG000'}, {'value': '-9.23', 'spread': '4.764', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.43', 'spread': '1.791', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '1.776', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.52', 'spread': '1.738', 'groupId': 'OG000'}, {'value': '8.64', 'spread': '1.727', 'groupId': 'OG001'}]}]}, {'title': 'hange from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.02', 'spread': '1.681', 'groupId': 'OG000'}, {'value': '8.84', 'spread': '1.672', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.07', 'spread': '1.816', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '1.814', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '-2.38', 'ciUpperLimit': '7.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.522', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.3893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.11', 'ciLowerLimit': '-2.72', 'ciUpperLimit': '6.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.450', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.2357', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.82', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '7.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.371', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}, {'pValue': '0.5839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '-3.66', 'ciUpperLimit': '6.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.567', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model: (Response Variable = Treatment + Stratification Factors \\[IGA-CPG-S/Region\\] + Visit + Treatment\\*Visit)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.51', 'spread': '17.081', 'groupId': 'OG000'}, {'value': '10.15', 'spread': '15.211', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.11', 'spread': '18.437', 'groupId': 'OG000'}, {'value': '11.25', 'spread': '14.900', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.33', 'spread': '18.678', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '17.273', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.87', 'spread': '20.519', 'groupId': 'OG000'}, {'value': '8.42', 'spread': '18.392', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.66', 'spread': '20.595', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '19.863', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.21', 'spread': '21.577', 'groupId': 'OG000'}, {'value': '9.44', 'spread': '20.883', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.00', 'spread': '24.181', 'groupId': 'OG000'}, {'value': '11.86', 'spread': '19.669', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.61', 'spread': '25.748', 'groupId': 'OG000'}, {'value': '9.82', 'spread': '18.112', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.48', 'spread': '26.776', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '18.219', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '29.412', 'groupId': 'OG000'}, {'value': '11.47', 'spread': '16.604', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.76', 'spread': '29.098', 'groupId': 'OG000'}, {'value': '12.00', 'spread': '12.916', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). 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': 'Open-label Extension Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 2, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.621', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.431', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.648', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.431', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.689', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.697', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.426', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.628', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.334', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.500', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.536', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.962', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.784', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.833', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.773', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.819', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.697', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.759', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.792', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.871', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.988', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.815', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '0.982', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.125', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.039', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.108', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.101', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.872', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.796', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.895', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.742', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.863', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.849', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.859', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.791', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). 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': 'OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'title': 'Change from Baseline at Week 14, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.578', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.686', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.682', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.718', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.557', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.525', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.460', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.549', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.510', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.485', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.280', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.331', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.576', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.429', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.680', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.354', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.378', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52, Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.470', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.277', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.637', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.413', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.612', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.414', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.775', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.711', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.615', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.385', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.477', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.408', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.670', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.432', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.680', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.315', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.367', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.258', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52, Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.277', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.727', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.893', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.744', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.968', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.958', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.841', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.697', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.840', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.623', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.767', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.630', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.948', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.591', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.140', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.485', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.910', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.429', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.958', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.458', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52, Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '1.029', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.408', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.078', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '1.009', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.102', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '1.055', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.102', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '1.094', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.998', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '1.045', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '1.041', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '1.062', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '1.111', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.124', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '1.020', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '1.154', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.791', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.284', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.781', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.451', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.915', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52, Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.334', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.899', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.806', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.910', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.895', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.930', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.819', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.999', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.743', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 28, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.882', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.768', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 32, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.859', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.955', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.713', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 40, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.945', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.862', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 44, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.102', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.920', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.816', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52, Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.966', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.877', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). 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': 'Open-label Extension Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 12', '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 can 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 cream. A TEAE was defined as any AE 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 or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.'}, {'type': 'SECONDARY', 'title': 'DBVC Period: Number of Participants With Any ≥Grade 3 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 12', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'OLE Period: Number of Participants With Any TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from beginning of Week 13 up to Week 56', '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 can 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 cream. A TEAE was defined as any AE 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 Population'}, {'type': 'SECONDARY', 'title': 'OLE Period: Number of Participants With Any ≥Grade 3 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'OG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from beginning of Week 13 up to Week 56', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'FG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}], 'periods': [{'title': '12-week DBVC Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': '40-week OLE Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Extended Travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '59'}]}]}], 'preAssignmentDetails': 'Data collected through a cut off date of 30 December 2024 have been included in this summary. Participants were enrolled at 190 sites in Australia, Austria, Bulgaria, Canada, France, Germany, Italy, South Korea, Poland, Spain, Switzerland, and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vehicle Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \\[IGA-CPG-S\\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'BG001', 'title': 'Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID', 'description': 'Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '15.39', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '14.83', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '15.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White/Caucasian', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-21', 'size': 978249, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-12T14:04', 'hasProtocol': True}, {'date': '2024-07-15', 'size': 569394, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-12T14:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05722912', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-03-01', 'resultsFirstSubmitDate': '2025-11-12', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-12', 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WI-NRS4 Response at Week 12', 'timeFrame': 'Baseline; Week 12', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.'}], 'secondaryOutcomes': [{'measure': 'WI-NRS4 Response at Week 4', 'timeFrame': 'Baseline; Week 4', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'Percentage of Participants With Overall-Treatment Success at Week 12', 'timeFrame': 'Baseline; Week 12', 'description': "Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\])."}, {'measure': 'Percentage of Participants With IGA-CPG-S-TS at Week 12', 'timeFrame': 'Baseline; Week 12', 'description': 'IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\]).'}, {'measure': 'WI-NRS4 Response at Day 7', 'timeFrame': 'Baseline; Day 7', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'WI-NRS4 Response at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'Time to ≥2-point Improvement From Baseline in WI-NRS Score', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'Time to ≥4-point Improvement From Baseline in WI-NRS Score', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.'}, {'measure': 'DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline', 'timeFrame': 'Baseline; up to Week 12', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.'}, {'measure': 'OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline', 'timeFrame': 'Baseline; up to Week 52', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.'}, {'measure': 'DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'OLE Period: Change from baseline in Skin Pain NRS score at each post-baseline visit'}, {'measure': 'Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \\[approximately 1-5 lesions\\]); 2, mild (few palpable pruriginous lesions \\[approximately 6-19 lesions\\]); 3, moderate (many palpable pruriginous lesions \\[approximately 20-100 lesions\\]); 4, severe (abundant palpable pruriginous lesions \\[over 100 lesions\\]). Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.'}, {'measure': 'Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \\[up to approximately 10% of all pruriginous lesions\\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \\[approximately 11%-25% of all pruriginous lesions\\]); 3, moderate (many pruriginous lesions have excoriations or crusts \\[approximately 26%-75% of all pruriginous lesions\\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \\[approximately 76%-100% of all pruriginous lesions\\]).'}, {'measure': 'DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.'}, {'measure': 'OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.'}, {'measure': 'DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.'}, {'measure': 'OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.'}, {'measure': 'DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 12', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit', 'timeFrame': 'Baseline; up to Week 52', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant\'s self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to Week 12', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.'}, {'measure': 'DBVC Period: Number of Participants With Any ≥Grade 3 TEAE', 'timeFrame': 'up to Week 12', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.'}, {'measure': 'OLE Period: Number of Participants With Any TEAE', 'timeFrame': 'from beginning of Week 13 up to Week 56', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.'}, {'measure': 'OLE Period: Number of Participants With Any ≥Grade 3 TEAE', 'timeFrame': 'from beginning of Week 13 up to Week 56', '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 can 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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PN', 'INCB18424-320', 'INCB18424', 'Prurigo', 'Prurigo Nodularis', 'Skin Diseases', 'Dermatitis', 'ruxolitinib'], 'conditions': ['Prurigo Nodularis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).', 'detailedDescription': 'The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of PN ≥ 3 months before screening.\n* ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \\<20% BSA.\n* IGA-CPG-S score of ≥ 2 at screening and baseline.\n* Baseline PN-related WI-NRS score ≥ 7.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Chronic pruritus due to a condition other than PN\n* Total estimated BSA treatment area (excluding the scalp) \\> 20%.\n* Neuropathic and psychogenic pruritus\n* Active atopic dermatitis lesions within 3 months of screening and baseline.\n* Uncontrolled thyroid function\n* Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.\n* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.\n* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline\n* Pregnant or lactating, or considering pregnancy.\n* History of alcoholism or drug addiction within 1 year\n* Known allergy or reaction to any of the components of the study drug.\n* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.\n* Employees of the sponsor or investigator or otherwise dependents of them.\n* The following participants are excluded in France:\n\n 1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.\n 2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.\n 3. Individuals not affiliated with the social security system.'}, 'identificationModule': {'nctId': 'NCT05764161', 'acronym': 'TRuE-PN2', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis', 'orgStudyIdInfo': {'id': 'INCB18424-320'}, 'secondaryIdInfos': [{'id': '2022-502461-23-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib 1.5% Cream', 'description': 'Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.', 'interventionNames': ['Drug: Ruxolitinib Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'Ruxolitinib Cream', 'type': 'DRUG', 'otherNames': ['Opzelura', 'INCB018424 phosphate cream'], 'description': 'Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.', 'armGroupLabels': ['Ruxolitinib 1.5% Cream']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'description': 'Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.', 'armGroupLabels': ['Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72758', 'city': 'Arkansas City', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Clinical Trials Center', 'geoPoint': {'lat': 33.60872, 'lon': -91.20678}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute Clinical Research Specialists Inc', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Cura Clinical Research', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Ars - Maitland Clinical Research Unit', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30060-1047', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marietta Dermatology the Skin Cancer Center Marietta', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'The South Bend Clinic Main Campus', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Axon Clinical Research', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Activmed Practices Research, Llc Beverly', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oakview Dermatology', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Inc-Dublin', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians, Inc.', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '18249', 'city': 'Sugarloaf', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dermdox Center For Dermatology', 'geoPoint': {'lat': 41.98343, 'lon': -76.12083}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermresearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '02217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Premier Specialists Pty Ltd', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '02170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '02010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Medical Practice', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '02145', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '04102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Research', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '03004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '02606', 'city': 'Phillip', 'country': 'Australia', 'facility': 'Paratus Clinical Research, Woden', 'geoPoint': {'lat': -35.35035, 'lon': 149.09151}}, {'zip': '08036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Landeskrankenhaus Universitatsklinikum Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '04020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz Gmbh Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '01220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Sozialmedizinisches Zentrum Ost-Donauspital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '05800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Medical Center Medconsult Pleven Ood', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '07000', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Medical Center- Prolet Ltd', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '05400', 'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Medical Center Unimed Eood', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'zip': '01431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': "Dcc 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