Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT03638258
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@arcutis.com', 'phone': '+1 (844) 692-6729', 'title': 'Arcutis Medical Information', 'organization': 'Arcutis Biotherapeutics'}, 'certainAgreement': {'otherDetails': 'The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 16 weeks', 'description': 'All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).', 'eventGroups': [{'id': 'EG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 8, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 113, 'otherNumAffected': 7, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Basal ganglia infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '30.6', 'groupId': 'OG001'}, {'value': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '16.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.174', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from placebo at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, and 12', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or last observation carried forward (LOCF) \\[subjects with assessments only before the missing assessment\\].'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-40.08', 'spread': '46.811', 'groupId': 'OG000'}, {'value': '-47.32', 'spread': '29.717', 'groupId': 'OG001'}, {'value': '-18.01', 'spread': '46.622', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-53.15', 'spread': '46.470', 'groupId': 'OG000'}, {'value': '-59.73', 'spread': '32.409', 'groupId': 'OG001'}, {'value': '-16.42', 'spread': '58.385', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-59.09', 'spread': '49.290', 'groupId': 'OG000'}, {'value': '-65.12', 'spread': '31.97', 'groupId': 'OG001'}, {'value': '-18.47', 'spread': '63.777', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-59.48', 'spread': '54.881', 'groupId': 'OG000'}, {'value': '-68.03', 'spread': '33.021', 'groupId': 'OG001'}, {'value': '-13.65', 'spread': '70.731', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head \\[h\\]: 10% of a person's skin; arms \\[a\\] 20%; trunk \\[t\\] 30%; legs (l\\] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Body Surface Area (BSA) Affected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-21.74', 'spread': '34.381', 'groupId': 'OG000'}, {'value': '-23.25', 'spread': '27.084', 'groupId': 'OG001'}, {'value': '-5.33', 'spread': '31.834', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-34.88', 'spread': '39.530', 'groupId': 'OG000'}, {'value': '-33.41', 'spread': '32.136', 'groupId': 'OG001'}, {'value': '-8.19', 'spread': '40.989', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-41.58', 'spread': '42.816', 'groupId': 'OG000'}, {'value': '-40.49', 'spread': '34.379', 'groupId': 'OG001'}, {'value': '-7.40', 'spread': '52.859', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-48.56', 'spread': '46.077', 'groupId': 'OG000'}, {'value': '-47.50', 'spread': '36.304', 'groupId': 'OG001'}, {'value': '-6.74', 'spread': '51.469', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream on Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline BSA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.", 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.116', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.423', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '43.7', 'groupId': 'OG001'}, {'value': '29.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}, {'value': '36.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference form vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.123', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.415', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.175', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.619', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 6, 8, and 12', 'description': 'The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '2.20', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.67', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean (SD) change in WI-NRS score from baseline is presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '24.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '57.0', 'groupId': 'OG001'}, {'value': '34.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}, {'value': '58.2', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '70.1', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.203', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.075', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a WI-NRS score ≥6 at baseline are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}, {'value': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}, {'value': '16.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.527', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.444', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.064', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '6.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '13.7', 'groupId': 'OG001'}, {'value': '7.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.188', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.577', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.664', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.666', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.163', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.", 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-32.7', 'spread': '34.61', 'groupId': 'OG000'}, {'value': '-32.7', 'spread': '35.08', 'groupId': 'OG001'}, {'value': '-22.9', 'spread': '31.85', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-37.8', 'spread': '35.71', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': '37.88', 'groupId': 'OG001'}, {'value': '-24.6', 'spread': '38.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-40.5', 'spread': '36.62', 'groupId': 'OG000'}, {'value': '-40.1', 'spread': '39.04', 'groupId': 'OG001'}, {'value': '-26.9', 'spread': '41.78', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-40.8', 'spread': '41.12', 'groupId': 'OG000'}, {'value': '-43.4', 'spread': '40.44', 'groupId': 'OG001'}, {'value': '-23.0', 'spread': '41.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream on Week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from placebo at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from placebo at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline PSD score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.74', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '3.08', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '3.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.184', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.207', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from placebo at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.'}, {'pValue': '0.01', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.', 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '4.29', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '4.23', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '4.23', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '4.57', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '4.77', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '4.92', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '5.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.255', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.687', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream on Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.059', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.051', 'groupIds': ['OG000'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Difference from vehicle cream at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.', 'nonInferiorityComment': 'Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") \\[2 questions are scored 0 to 3 and 8 questions are scored 0 to 4\\]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was added in protocol amendment 1. All participants randomized after implementing amendment 1 are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}, {'type': 'SECONDARY', 'title': 'Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'OG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'classes': [{'title': 'Week 4: Itching', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '3.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: Pain', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '2.89', 'groupId': 'OG002'}]}]}, {'title': 'Week 6: Itching', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.80', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '2.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 6: Pain', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.70', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Itching', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.92', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: Pain', 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.76', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Itching', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.14', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Pain', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 6, 8, and 12', 'description': 'Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rolumilast Cream 0.3%', 'description': 'Roflumilast (ARQ-151) cream 0.3% was topically applied once daily (QD) for 12 weeks.'}, {'id': 'FG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast (ARQ-151) cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'FG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Adult (≥18 years of age) male or female participants with chronic plaque psoriasis were recruited at 30 study sites in the US and Canada.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% was topically applied QD for 12 weeks.'}, {'id': 'BG001', 'title': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% was topically applied QD for 12 weeks.'}, {'id': 'BG002', 'title': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '51.7', 'spread': '14.11', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '14.20', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '13.49', 'groupId': 'BG002'}, {'value': '53.9', 'spread': '13.99', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Whole Body Investigator Global Assessment (IGA) Score', 'classes': [{'title': '0 - Clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '1 - Almost Clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '2 - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': '3 - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}]}, {'title': '4 - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.", 'unitOfMeasure': 'Participants'}, {'title': 'Intertriginous Area Investigator Global Assessment (I-IGA) Score', 'classes': [{'title': '1 - Almost Clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': '2 - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': '3 - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': '4 - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.", 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants with intertriginous area involvement are included.'}, {'title': 'Itch-Related Sleep Loss Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.24', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '3.19', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '3.18', 'groupId': 'BG002'}, {'value': '3.1', 'spread': '3.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. Higher scores indicate greater symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of Body Surface Area (BSA) Affected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.33', 'spread': '4.005', 'groupId': 'BG000'}, {'value': '6.44', 'spread': '3.915', 'groupId': 'BG001'}, {'value': '6.43', 'spread': '3.597', 'groupId': 'BG002'}, {'value': '6.40', 'spread': '3.833', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of body surface area', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Psoriasis Area Severity Index (mPASI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.94', 'spread': '3.959', 'groupId': 'BG000'}, {'value': '6.33', 'spread': '4.363', 'groupId': 'BG001'}, {'value': '5.77', 'spread': '3.498', 'groupId': 'BG002'}, {'value': '6.02', 'spread': '3.956', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The mPASI combines assessment of the severity of lesions and the area affected into a single score ranging from 0 (\'no disease\') to 72 (\'maximal disease\'), with higher scores indicating greater severity. The body is divided into four sections (head (h) (10% of a person\'s skin); arms (a) (20%); trunk (t) (30%); legs (l) (40%)). Each of these areas is scored alone, and then the four scores are combined into the final mPASI. For each section, the percent of area (A) of skin involved is estimated and then transformed into a grade from 0 ("0% of area involved") to 6 ("90 to 100% of involved area").', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Worst Itch - Numerical Rating Scale (WI-NRS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.67', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '3.05', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '2.87', 'groupId': 'BG002'}, {'value': '5.9', 'spread': '2.87', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Psoriasis Symptom Diary (PSD) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '68.9', 'spread': '41.18', 'groupId': 'BG000'}, {'value': '69.6', 'spread': '46.20', 'groupId': 'BG001'}, {'value': '75.1', 'spread': '42.55', 'groupId': 'BG002'}, {'value': '71.2', 'spread': '43.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dermatology Life Quality Index (DLQI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '5.50', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '7.15', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '5.62', 'groupId': 'BG002'}, {'value': '8.0', 'spread': '6.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-12', 'size': 2153004, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-20T12:50', 'hasProtocol': True}, {'date': '2019-05-30', 'size': 5665094, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-20T12:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group, double blind, vehicle-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2020-08-10', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2018-08-16', 'dispFirstSubmitQcDate': '2022-07-13', 'resultsFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2018-08-17', 'dispFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-13', 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6", 'timeFrame': 'Week 6', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity."}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'", 'timeFrame': 'Weeks 4, 8, and 12', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity."}, {'measure': 'Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head \\[h\\]: 10% of a person's skin; arms \\[a\\] 20%; trunk \\[t\\] 30%; legs (l\\] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al."}, {'measure': 'Percent Change From Baseline in Body Surface Area (BSA) Affected', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented."}, {'measure': "Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline", 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity."}, {'measure': "Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline", 'timeFrame': 'Weeks 4, 6, 8, and 12', 'description': 'The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.'}, {'measure': 'Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean (SD) change in WI-NRS score from baseline is presented.'}, {'measure': 'Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.'}, {'measure': 'Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity."}, {'measure': 'Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': "The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented."}, {'measure': 'Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.'}, {'measure': 'Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 6, 8, and 12', 'description': 'The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") \\[2 questions are scored 0 to 3 and 8 questions are scored 0 to 4\\]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.'}, {'measure': 'Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)', 'timeFrame': 'Weeks 4, 6, 8, and 12', 'description': 'Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '36370336', 'type': 'DERIVED', 'citation': 'Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.'}, {'pmid': '32668113', 'type': 'DERIVED', 'citation': 'Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.'}]}, 'descriptionModule': {'briefSummary': 'This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants legally competent to sign and give informed consent\n* Males and females ages 18 years and older (inclusive)\n* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator\n* Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.\n* In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.\n* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.\n\nExclusion Criteria:\n\n* Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.\n* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.\n* Previous treatment with roflumilast cream or its active ingredient\n* Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.\n* Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.\n* Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation."}, 'identificationModule': {'nctId': 'NCT03638258', 'acronym': 'ARQ-151-201', 'briefTitle': 'The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcutis Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'ARQ-151-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Roflumilast Cream 0.3%', 'description': 'Roflumilast cream 0.3% topically applied QD for 12 weeks.', 'interventionNames': ['Drug: Roflumilast Cream 0.3%']}, {'type': 'EXPERIMENTAL', 'label': 'Roflumilast Cream 0.15%', 'description': 'Roflumilast cream 0.15% topically applied QD for 12 weeks.', 'interventionNames': ['Drug: Roflumilast Cream 0.15%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'Roflumilast Cream 0.3%', 'type': 'DRUG', 'otherNames': ['ARQ-151'], 'description': 'Applied once daily for 12 weeks', 'armGroupLabels': ['Roflumilast Cream 0.3%']}, {'name': 'Roflumilast Cream 0.15%', 'type': 'DRUG', 'otherNames': ['ARQ-151'], 'description': 'Applied once daily for 12 weeks', 'armGroupLabels': ['Roflumilast Cream 0.15%']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'description': 'Applied once daily for 12 weeks', 'armGroupLabels': ['Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 35', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 29', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 28', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 27', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 12', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 16', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Arcutis Clinical Site 21', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 34', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 33', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Arcutis Clinical Site 20', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Arcutis Clinical Site 22', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Arcutis Clinical Site 14', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arcutis Clinical Site 39', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Arcutis Clinical Site 15', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 19', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 37', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 13', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 23', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 24', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Arcutis Clinical Site 31', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 18', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V3V 0C6', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 11', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 38', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L1S 7K8', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 10', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'N6H 5L5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 25', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3P 1X2', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 26', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 32', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 17', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 30', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N8W 1E6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 36', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'David Berk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcutis Biotherapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcutis Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}