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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 1:39 AM

Ignite Modification Date: 2026-04-13 @ 5:45 AM

Study NCT ID: NCT00617994

Status: COMPLETED

Last Update Posted: 2022-02-08

First Post: 2008-01-21

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463', 'title': 'Incyte Corporation Call Center (US)', 'organization': 'Incyte'}, 'certainAgreement': {'otherDetails': 'Clinical Study Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort A', 'description': '2 to 7% of BSA treated BID with INCB018424 1.5% cream', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort B', 'description': '8 to 13% of BSA treated BID with INCB018424 1.5% cream BID', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort C', 'description': '14 to 20% of BSA treated QD with INCB018424 1.5% cream QD', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort D', 'description': '14-20% of BSA with INCB018424 1.0% cream BID', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort E', 'description': '14 to 20% of BSA treated BID with INCB018424 1.5% cream BID', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 11, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Reticulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Treatment of Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 3 months', 'description': 'Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Parameter : Skin Flux of INCB018424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'spread': '126', 'groupId': 'OG000'}, {'value': '131', 'spread': '92', 'groupId': 'OG001'}, {'value': '60', 'spread': '43', 'groupId': 'OG002'}, {'value': '151', 'spread': '126', 'groupId': 'OG003'}, {'value': '152', 'spread': '74', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 4, 8, 15, 22, and 28-30', 'description': 'The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.', 'unitOfMeasure': 'ng/cm^2/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Parameter: Bioavailability of INCB018424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '1.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately one month: Days 1, 4, 8, 15, 22, and 28', 'description': 'The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Control Lesion', 'description': 'Control Lesions were not treated.'}, {'id': 'OG001', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort B: Control Lesion', 'description': 'Control Lesions were not treated.'}, {'id': 'OG003', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG004', 'title': 'Cohort C: Control Lesion', 'description': 'Control Lesions were not treated.'}, {'id': 'OG005', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG006', 'title': 'Cohort D: Control Lesion', 'description': 'Control Lesions were not treated.'}, {'id': 'OG007', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG008', 'title': 'Cohort E: Control Lesion', 'description': 'Control Lesions were not treated.'}, {'id': 'OG009', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'title': 'Day 8', 'categories': [{'measurements': [{'value': '.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '1'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-4.0', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '-2'}, {'value': '-0.2', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '-1.2', 'groupId': 'OG005', 'lowerLimit': '-5', 'upperLimit': '1'}, {'value': '-0.2', 'groupId': 'OG006', 'lowerLimit': '-2', 'upperLimit': '1'}, {'value': '-1.2', 'groupId': 'OG007', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '0.2', 'groupId': 'OG008', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '-2.8', 'groupId': 'OG009', 'lowerLimit': '-5', 'upperLimit': '2'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '2'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '-2'}, {'value': '-2.00', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '-1'}, {'value': '-4.2', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '-2'}, {'value': '-0.6', 'groupId': 'OG004', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '-2.6', 'groupId': 'OG005', 'lowerLimit': '-7', 'upperLimit': '0'}, {'value': '0.8', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '-0.8', 'groupId': 'OG007', 'lowerLimit': '-4', 'upperLimit': '0'}, {'value': '-0.8', 'groupId': 'OG008', 'lowerLimit': '-4', 'upperLimit': '0'}, {'value': '-3.6', 'groupId': 'OG009', 'lowerLimit': '-6', 'upperLimit': '-2'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '-2.8', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '0'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '-1'}, {'value': '-5.0', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '-2'}, {'value': '-2.8', 'groupId': 'OG004', 'lowerLimit': '-6', 'upperLimit': '0'}, {'value': '-3.6', 'groupId': 'OG005', 'lowerLimit': '-7', 'upperLimit': '-1'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '-2.8', 'groupId': 'OG007', 'lowerLimit': '-6', 'upperLimit': '-1'}, {'value': '-0.4', 'groupId': 'OG008', 'lowerLimit': '-3', 'upperLimit': '1'}, {'value': '-3.6', 'groupId': 'OG009', 'lowerLimit': '-7', 'upperLimit': '-2'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '2'}, {'value': '-3.4', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '-2'}, {'value': '-2.0', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '0'}, {'value': '-5.4', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '-3'}, {'value': '-3.6', 'groupId': 'OG004', 'lowerLimit': '-8', 'upperLimit': '0'}, {'value': '-4.4', 'groupId': 'OG005', 'lowerLimit': '-8', 'upperLimit': '-2'}, {'value': '0.6', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '-3.6', 'groupId': 'OG007', 'lowerLimit': '-5', 'upperLimit': '-2'}, {'value': '-1.2', 'groupId': 'OG008', 'lowerLimit': '-6', 'upperLimit': '0'}, {'value': '-3.8', 'groupId': 'OG009', 'lowerLimit': '-7', 'upperLimit': '-2'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '1'}, {'value': '-3.6', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '0'}, {'value': '-4.2', 'groupId': 'OG004', 'lowerLimit': '-9', 'upperLimit': '0'}, {'value': '-3.2', 'groupId': 'OG005', 'lowerLimit': '-9', 'upperLimit': '1'}, {'value': '0.6', 'groupId': 'OG006', 'lowerLimit': '-1', 'upperLimit': '2'}, {'value': '-1.0', 'groupId': 'OG007', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-2.0', 'groupId': 'OG008', 'lowerLimit': '-6', 'upperLimit': '0'}, {'value': '-2.8', 'groupId': 'OG009', 'lowerLimit': '-7', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)', 'description': 'Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.', 'unitOfMeasure': 'Change in Total Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Psoriatic Lesion Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Control Lesion', 'description': 'Control lesions were not treated.'}, {'id': 'OG001', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort B: Control Lesion', 'description': 'Control lesions were not treated.'}, {'id': 'OG003', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG004', 'title': 'Cohort C: Control Lesion', 'description': 'Control lesions were not treated.'}, {'id': 'OG005', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG006', 'title': 'Cohort D: Control Lesion', 'description': 'Control lesions were untreated.'}, {'id': 'OG007', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG008', 'title': 'Control E: Control Lesion', 'description': 'Control Lesions were untreated.'}, {'id': 'OG009', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'spread': '23.993', 'groupId': 'OG000'}, {'value': '-237.76', 'spread': '240.500', 'groupId': 'OG001'}, {'value': '-15.94', 'spread': '38.247', 'groupId': 'OG002'}, {'value': '-620.56', 'spread': '714.829', 'groupId': 'OG003'}, {'value': '0.40', 'spread': '11.336', 'groupId': 'OG004'}, {'value': '-1267.78', 'spread': '1009.159', 'groupId': 'OG005'}, {'value': '-9.02', 'spread': '10.346', 'groupId': 'OG006'}, {'value': '-871.12', 'spread': '1062.346', 'groupId': 'OG007'}, {'value': '-12.32', 'spread': '23.283', 'groupId': 'OG008'}, {'value': '-823.78', 'spread': '313.733', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 28', 'description': 'The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Physicians Global Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG004'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '3.0', 'spread': '0.00', 'groupId': 'OG004'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '3.2', 'spread': '0.45', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later', 'description': "The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.\n\nNote that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.", 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'OG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'OG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'OG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '28.38', 'spread': '13.10', 'groupId': 'OG001'}, {'value': '24.41', 'spread': '10.07', 'groupId': 'OG002'}, {'value': '34.97', 'spread': '20.44', 'groupId': 'OG003'}, {'value': '60.98', 'spread': '73.85', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately one month: Days 1, 4, 8, 15, 22, and 28', 'description': 'All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'FG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'FG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'FG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'FG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 6 study centers in the United States from 08 November 2007 to 13 April 2009. This study is completed.', 'preAssignmentDetails': 'A total of 25 participants with active but stable plaque psoriasis were enrolled in the dose-escalation study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A', 'description': '2% to 7% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'BG001', 'title': 'Cohort B', 'description': '8% to 13% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'BG002', 'title': 'Cohort C', 'description': '14% to 20% of BSA treated QD with INCB018424 1.5% cream'}, {'id': 'BG003', 'title': 'Cohort D', 'description': '14% to 20% of BSA treated BID with INCB018424 1.0% cream'}, {'id': 'BG004', 'title': 'Cohort E', 'description': '14% to 20% of BSA treated BID with INCB018424 1.5% cream'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '6.22', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '7.57', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '13.94', 'groupId': 'BG002'}, {'value': '46.2', 'spread': '12.21', 'groupId': 'BG003'}, {'value': '42.8', 'spread': '18.16', 'groupId': 'BG004'}, {'value': '40.5', 'spread': '12.36', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian/Alaskan Native White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT: The intent-to-treat (ITT) population included all enrolled participants who applied INCB018424 cream at least once and had a predose and at least one post-dose lesion assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2010-06-28', 'completionDateStruct': {'date': '2009-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2008-01-21', 'dispFirstSubmitQcDate': '2010-06-28', 'resultsFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2008-02-06', 'dispFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-04', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment of Emergent Adverse Events', 'timeFrame': 'Approximately 3 months', 'description': 'Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment'}, {'measure': 'Pharmacokinetics Parameter : Skin Flux of INCB018424', 'timeFrame': 'Days 1, 4, 8, 15, 22, and 28-30', 'description': 'The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.'}, {'measure': 'Pharmacokinetics Parameter: Bioavailability of INCB018424', 'timeFrame': 'Approximately one month: Days 1, 4, 8, 15, 22, and 28', 'description': 'The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.'}, {'measure': 'Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424', 'timeFrame': 'Approximately one month: Days 1, 4, 8, 15, 22, and 28', 'description': 'All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.'}], 'secondaryOutcomes': [{'measure': 'Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline', 'timeFrame': 'Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)', 'description': 'Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.'}, {'measure': 'Mean Change in Psoriatic Lesion Area', 'timeFrame': 'Days 1 and 28', 'description': 'The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.'}, {'measure': 'Mean Change in Physicians Global Assessment Score', 'timeFrame': 'Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later', 'description': "The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.\n\nNote that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have psoriatic lesions measuring protocol specific BSA\n\nExclusion Criteria:\n\n* Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face\n* Pustular psoriasis or erythroderma'}, 'identificationModule': {'nctId': 'NCT00617994', 'briefTitle': 'Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).', 'orgStudyIdInfo': {'id': 'INCB 18424-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.', 'interventionNames': ['Drug: Ruxolitinib']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib 1.5% cream BID for 28 days', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77840', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}], 'overallOfficials': [{'name': 'William Williams, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}