Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 1:17 AM
Study NCT ID:
NCT01107457
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2010-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Participants With Moderate to Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549079', 'term': 'ixekizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Treatment durability refers to participants who had a PASI 75 response at Week 20 and remained in Part A of the study from Week 20-32 (treatment-free period). These participants moved to Part B of the study upon completion of Part A through Week 32 or upon loss of PASI75 response during the Part A treatment-free period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.', 'otherNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.', 'otherNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.', 'otherNumAtRisk': 30, 'otherNumAffected': 12, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.', 'otherNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.', 'otherNumAtRisk': 28, 'otherNumAffected': 11, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment Durability', 'description': 'Part A: Treatment durability/safety follow-up period:12 to 20 weeks.', 'otherNumAtRisk': 74, 'otherNumAffected': 11, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': '120 mg and 80 mg Total Ixekizumab', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.', 'otherNumAtRisk': 120, 'otherNumAffected': 82, 'seriousNumAtRisk': 120, 'seriousNumAffected': 24}, {'id': 'EG007', 'title': 'Post Treatment Safety Visits', 'description': 'Participants who were followed due to neutropenia.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 57, 'numAffected': 29}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '76.7', 'groupId': 'OG002'}, {'value': '82.8', 'groupId': 'OG003'}, {'value': '82.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'PRIMARY', 'title': 'Percentage of PASI Improvement From Baseline to 12 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.22', 'groupId': 'OG000', 'lowerLimit': '4.44', 'upperLimit': '28.01'}, {'value': '49.33', 'groupId': 'OG001', 'lowerLimit': '38.25', 'upperLimit': '60.41'}, {'value': '78.48', 'groupId': 'OG002', 'lowerLimit': '67.67', 'upperLimit': '89.29'}, {'value': '85.69', 'groupId': 'OG003', 'lowerLimit': '74.87', 'upperLimit': '96.50'}, {'value': '87.12', 'groupId': 'OG004', 'lowerLimit': '75.94', 'upperLimit': '98.29'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.', 'unitOfMeasure': 'Percentage of improvement in PASI score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Static Physician\'s Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '72.4', 'groupId': 'OG003'}, {'value': '71.4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to 20 Weeks', 'description': "Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-2.17', 'spread': '0.54', 'groupId': 'OG003'}, {'value': '-2.81', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '-2.52', 'spread': '0.51', 'groupId': 'OG003'}, {'value': '-2.01', 'spread': '0.51', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-1.48', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-2.13', 'spread': '0.52', 'groupId': 'OG003'}, {'value': '-2.21', 'spread': '0.54', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance \\[initial, middle and late insomnia or hypersomnia\\], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PatGA) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.3', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '0.3', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.87', 'groupId': 'OG000', 'lowerLimit': '-20.90', 'upperLimit': '28.64'}, {'value': '-4.32', 'groupId': 'OG001', 'lowerLimit': '-23.05', 'upperLimit': '14.41'}, {'value': '-19.36', 'groupId': 'OG002', 'lowerLimit': '-34.31', 'upperLimit': '-4.40'}, {'value': '-21.24', 'groupId': 'OG003', 'lowerLimit': '-37.89', 'upperLimit': '-4.58'}, {'value': '-34.24', 'groupId': 'OG004', 'lowerLimit': '-51.83', 'upperLimit': '-16.66'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.", 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'title': 'Sleep Problems Index I', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-5.35', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-8.78', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '-7.97', 'spread': '2.42', 'groupId': 'OG003'}, {'value': '-2.38', 'spread': '2.47', 'groupId': 'OG004'}]}]}, {'title': 'Sleep Problems Index II', 'categories': [{'measurements': [{'value': '0.21', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-6.42', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '-9.23', 'spread': '2.20', 'groupId': 'OG002'}, {'value': '-8.43', 'spread': '2.20', 'groupId': 'OG003'}, {'value': '-2.48', 'spread': '2.24', 'groupId': 'OG004'}]}]}, {'title': 'Sleep Adequacy', 'categories': [{'measurements': [{'value': '-2.83', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '4.47', 'groupId': 'OG001'}, {'value': '11.35', 'spread': '4.39', 'groupId': 'OG002'}, {'value': '8.81', 'spread': '4.39', 'groupId': 'OG003'}, {'value': '-0.41', 'spread': '4.48', 'groupId': 'OG004'}]}]}, {'title': 'Sleep Disturbance', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-8.56', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '-10.02', 'spread': '3.03', 'groupId': 'OG002'}, {'value': '-11.50', 'spread': '3.04', 'groupId': 'OG003'}, {'value': '-4.67', 'spread': '3.09', 'groupId': 'OG004'}]}]}, {'title': 'Sleep Somnolence', 'categories': [{'measurements': [{'value': '1.12', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-7.14', 'spread': '2.53', 'groupId': 'OG002'}, {'value': '-5.80', 'spread': '2.53', 'groupId': 'OG003'}, {'value': '-0.76', 'spread': '2.58', 'groupId': 'OG004'}]}]}, {'title': 'Snoring', 'categories': [{'measurements': [{'value': '-2.85', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '3.94', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '3.88', 'groupId': 'OG002'}, {'value': '-3.24', 'spread': '3.87', 'groupId': 'OG003'}, {'value': '-3.81', 'spread': '3.94', 'groupId': 'OG004'}]}]}, {'title': 'Sleep Short of Breath/headache', 'categories': [{'measurements': [{'value': '4.34', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '-5.45', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '-2.84', 'spread': '2.87', 'groupId': 'OG002'}, {'value': '-2.65', 'spread': '2.87', 'groupId': 'OG003'}, {'value': '-3.46', 'spread': '2.91', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \\* 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'title': 'Week 16 - Office or Clinic(n=23,24,29,28,27)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 16 - Emergency Room(ER)(n=23, 24, 29, 28, 27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 16 - Admitted thru ER (n=26,28,30,29,28)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 16 - Hospital Stay (n=26,28,30,29,28)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The PMRU is a 3-item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'title': 'Absenteeism (n=15,19,14,19,16)', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '1.94', 'groupId': 'OG002'}, {'value': '-2.64', 'spread': '1.67', 'groupId': 'OG003'}, {'value': '-1.96', 'spread': '1.82', 'groupId': 'OG004'}]}]}, {'title': 'Presenteeism (n=15,20,16,19,16)', 'categories': [{'measurements': [{'value': '-3.38', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '3.47', 'groupId': 'OG001'}, {'value': '-4.59', 'spread': '3.87', 'groupId': 'OG002'}, {'value': '-14.48', 'spread': '3.55', 'groupId': 'OG003'}, {'value': '-10.69', 'spread': '3.90', 'groupId': 'OG004'}]}]}, {'title': 'Work productivity loss (n=15,19,14,19,16)', 'categories': [{'measurements': [{'value': '-3.65', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '3.82', 'groupId': 'OG001'}, {'value': '-4.65', 'spread': '4.45', 'groupId': 'OG002'}, {'value': '-14.76', 'spread': '3.82', 'groupId': 'OG003'}, {'value': '-11.12', 'spread': '4.17', 'groupId': 'OG004'}]}]}, {'title': 'Activity Impairment (n=25,28,28,29,27)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '-9.76', 'spread': '3.96', 'groupId': 'OG001'}, {'value': '-14.96', 'spread': '3.95', 'groupId': 'OG002'}, {'value': '-12.81', 'spread': '3.90', 'groupId': 'OG003'}, {'value': '-14.79', 'spread': '4.03', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))\\*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) \\*100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\]) \\* 100 and Activity Impairment = (Q6/10) \\* 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'title': 'PCS', 'categories': [{'measurements': [{'value': '-1.22', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '1.95', 'spread': '2.03', 'groupId': 'OG002'}, {'value': '3.94', 'spread': '2.00', 'groupId': 'OG003'}, {'value': '5.72', 'spread': '2.03', 'groupId': 'OG004'}]}]}, {'title': 'MCS', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '5.16', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '4.13', 'spread': '2.13', 'groupId': 'OG003'}, {'value': '4.15', 'spread': '2.16', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '-5.17', 'upperLimit': '9.58'}, {'value': '-4.85', 'groupId': 'OG001', 'lowerLimit': '-12.82', 'upperLimit': '3.12'}, {'value': '-3.65', 'groupId': 'OG002', 'lowerLimit': '-12.73', 'upperLimit': '5.43'}, {'value': '-15.89', 'groupId': 'OG003', 'lowerLimit': '-24.98', 'upperLimit': '-6.81'}, {'value': '-19.91', 'groupId': 'OG004', 'lowerLimit': '-29.00', 'upperLimit': '-10.83'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \\[absence of psoriasis\\] to 4 \\[presence of psoriasis in all 4 quadrants\\]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If \\<50% of the toes or finger assessments were missing, the imputation was performed. If \\>50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-10.3', 'upperLimit': '8.3'}, {'value': '-6.4', 'groupId': 'OG001', 'lowerLimit': '-12.3', 'upperLimit': '-0.5'}, {'value': '-4.6', 'groupId': 'OG002', 'lowerLimit': '-10.3', 'upperLimit': '1.2'}, {'value': '-3.4', 'groupId': 'OG003', 'lowerLimit': '-11.5', 'upperLimit': '4.8'}, {'value': '-12.8', 'groupId': 'OG004', 'lowerLimit': '-20.9', 'upperLimit': '-4.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '-3.5'}, {'value': '-10.2', 'groupId': 'OG001', 'lowerLimit': '-13.9', 'upperLimit': '-6.6'}, {'value': '-15.8', 'groupId': 'OG002', 'lowerLimit': '-19.2', 'upperLimit': '-12.4'}, {'value': '-15.0', 'groupId': 'OG003', 'lowerLimit': '-18.9', 'upperLimit': '-11.0'}, {'value': '-17.2', 'groupId': 'OG004', 'lowerLimit': '-20.8', 'upperLimit': '-13.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0177', 'groupId': 'OG000', 'lowerLimit': '0.0160', 'upperLimit': '0.0199'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32', 'description': 'The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.', 'unitOfMeasure': 'liters per hour (L/hr)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-6.35', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-6.59', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '-8.39', 'spread': '0.90', 'groupId': 'OG003'}, {'value': '-8.17', 'spread': '0.92', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.50', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '13.56', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '14.99', 'spread': '1.14', 'groupId': 'OG003'}, {'value': '15.38', 'spread': '1.16', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region\\*area score\\*weighing factor (head\\[0.1\\],upper limbs\\[0.2\\],trunk\\[0.3\\],lower limbs \\[0.4\\]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '59.1', 'groupId': 'OG002'}, {'value': '56.5', 'groupId': 'OG003'}, {'value': '82.6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Percentage of PASI Improvement From Baseline Through 32 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.55', 'spread': '17.69', 'groupId': 'OG001'}, {'value': '85.60', 'spread': '12.74', 'groupId': 'OG002'}, {'value': '85.16', 'spread': '15.30', 'groupId': 'OG003'}, {'value': '88.11', 'spread': '11.35', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Through 32 Weeks', 'description': 'The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.', 'unitOfMeasure': 'Percentage PASI improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '47.8', 'groupId': 'OG003'}, {'value': '65.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Ixekizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}, {'id': 'OG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '17.2', 'groupId': 'OG003'}, {'value': '22.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 20', 'description': 'Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \\* 100%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who had PASI 75 response at Week 20.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events up to 344 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Up to 344 Weeks', 'description': "Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who had PASI 75 response at Week 20.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'title': '0(Clear)', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '5(Severe)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 240', 'description': 'The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who had PASI 75 response at Week 20.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.25', 'spread': '32.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.", 'unitOfMeasure': 'Millimeters (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.62', 'spread': '30.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \\[absence of psoriasis\\] to 4 \\[presence of psoriasis in all 4 quadrants\\]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If \\<50% of the toes or finger assessments were missing, the imputation was performed. If \\>50% of the assessments were missing, then the sum of the scores was left as missing.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with baseline nail psoriasis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.89', 'spread': '13.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with baseline scalp psoriasis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.10', 'spread': '7.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with baseline palmoplantar psoriasis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 240', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who had PASI 75 response at Week 20.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Ixekizumab (80 mg and 120 mg)', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nDuring Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who had PASI 75 response at Week 20.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'FG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'FG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'FG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'FG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\nAdministered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\nAdministered 80 mg ixekizumab SC Q4W through week 344.'}, {'id': 'FG005', 'title': '120 mg/80 mg Total Ixekizumab', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'comment': '120 mg and 80 mg ixekizumab were administered during Part B and C.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'comment': '120 mg and 80 mg ixekizumab were administered during Part B and C.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'comment': '120 mg and 80 mg ixekizumab were administered during Part B and C.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part B and C', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '80 and 120 mg ixekizumab were administered during Part B and C.', 'groupId': 'FG005', 'numSubjects': '120'}]}, {'type': 'Completed Part B (Week 240)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '74'}]}, {'type': 'Completed Part C', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Part C was stopped once ixekizumab became available through marketing authorization.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Post Treatment Safety Visits', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Only participants with neutropenia entered the post treatment safety visits.', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'No participants completed the study as Part C was stopped.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Inclusion/Exclusion Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '66'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'Clinical Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks \\[wks\\]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.', 'preAssignmentDetails': 'Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '142', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'BG001', 'title': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'BG002', 'title': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'BG003', 'title': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through week 344.'}, {'id': 'BG004', 'title': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\nAdministered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\nAdministered 80 mg ixekizumab SC Q4W through week 344.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '12.76', 'groupId': 'BG000'}, {'value': '47.65', 'spread': '11.20', 'groupId': 'BG001'}, {'value': '45.93', 'spread': '14.53', 'groupId': 'BG002'}, {'value': '46.37', 'spread': '12.50', 'groupId': 'BG003'}, {'value': '45.97', 'spread': '13.00', 'groupId': 'BG004'}, {'value': '46.19', 'spread': '12.71', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '129', 'groupId': 'BG005'}]}, {'title': 'More than one race', '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': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '139', 'groupId': 'BG005'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline in Psoriasis Area and Severity Index (PASI)', 'classes': [{'categories': [{'measurements': [{'value': '16.45', 'spread': '5.26', 'groupId': 'BG000'}, {'value': '19.18', 'spread': '7.96', 'groupId': 'BG001'}, {'value': '18.55', 'spread': '4.94', 'groupId': 'BG002'}, {'value': '17.20', 'spread': '4.26', 'groupId': 'BG003'}, {'value': '17.70', 'spread': '6.21', 'groupId': 'BG004'}, {'value': '17.83', 'spread': '5.85', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]).Overall scores range from 0 (no psoriasis) to 72(the most severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2011-04-05', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2010-04-14', 'dispFirstSubmitQcDate': '2011-04-05', 'resultsFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2010-04-20', 'dispFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement', 'timeFrame': 'Week 12', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.'}, {'measure': 'Percentage of PASI Improvement From Baseline to 12 Week Endpoint', 'timeFrame': 'Baseline to Week 12', 'description': 'The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Static Physician\'s Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12', 'timeFrame': 'Week 12', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks', 'timeFrame': 'Baseline Up to 20 Weeks', 'description': "Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section."}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.'}, {'measure': 'Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance \\[initial, middle and late insomnia or hypersomnia\\], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PatGA) at Week 12', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.'}, {'measure': 'Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured."}, {'measure': 'Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \\* 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.'}, {'measure': 'Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))', 'timeFrame': 'Week 16', 'description': 'The PMRU is a 3-item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))\\*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) \\*100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\]) \\* 100 and Activity Impairment = (Q6/10) \\* 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.'}, {'measure': 'Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model."}, {'measure': 'Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \\[absence of psoriasis\\] to 4 \\[presence of psoriasis in all 4 quadrants\\]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If \\<50% of the toes or finger assessments were missing, the imputation was performed. If \\>50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects."}, {'measure': 'Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.'}, {'measure': 'Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.'}, {'measure': 'Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)', 'timeFrame': 'Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32', 'description': 'The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.'}, {'measure': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region\\*area score\\*weighing factor (head\\[0.1\\],upper limbs\\[0.2\\],trunk\\[0.3\\],lower limbs \\[0.4\\]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.'}, {'measure': 'Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)', 'timeFrame': 'Week 32', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.'}, {'measure': 'Percentage of PASI Improvement From Baseline Through 32 Weeks', 'timeFrame': 'Baseline Through 32 Weeks', 'description': 'The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.'}, {'measure': "Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement", 'timeFrame': 'Week 32', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline."}, {'measure': 'Percentage of Participants With Anti-Ixekizumab Antibodies', 'timeFrame': 'Baseline through Week 20', 'description': 'Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \\* 100%.'}, {'measure': "Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)", 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \\[clear\\] to 5 \\[severe\\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline."}, {'measure': 'Number of Treatment Emergent Adverse Events up to 344 Weeks', 'timeFrame': 'Baseline Up to 344 Weeks', 'description': "Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section."}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.'}, {'measure': "Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)", 'timeFrame': 'Week 240', 'description': 'The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).'}, {'measure': 'Change From Baseline in Pain Visual Analog Scale (VAS)', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used."}, {'measure': 'Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': "The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \\[absence of psoriasis\\] to 4 \\[presence of psoriasis in all 4 quadrants\\]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If \\<50% of the toes or finger assessments were missing, the imputation was performed. If \\>50% of the assessments were missing, then the sum of the scores was left as missing.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study."}, {'measure': 'Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study.'}, {'measure': 'Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.'}, {'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement', 'timeFrame': 'Week 240', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor (head \\[0.1\\], upper limbs \\[0.2\\], trunk \\[0.3\\], lower limbs \\[0.4\\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline Up to 240 Weeks', 'description': 'The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.\n\nBaseline is defined as the last available value prior to the first dose in Part A of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate', 'Severe', 'Plaque', 'Chronic'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '25693783', 'type': 'DERIVED', 'citation': 'Langley RG, Rich P, Menter A, Krueger G, Goldblum O, Dutronc Y, Zhu B, Wei H, Cameron GS, Heffernan MP. Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1763-70. doi: 10.1111/jdv.12996. Epub 2015 Feb 18.'}, {'pmid': '25242558', 'type': 'DERIVED', 'citation': 'Gordon KB, Leonardi CL, Lebwohl M, Blauvelt A, Cameron GS, Braun D, Erickson J, Heffernan M. A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2014 Dec;71(6):1176-82. doi: 10.1016/j.jaad.2014.07.048. Epub 2014 Sep 19.'}, {'pmid': '22455413', 'type': 'DERIVED', 'citation': 'Leonardi C, Matheson R, Zachariae C, Cameron G, Li L, Edson-Heredia E, Braun D, Banerjee S. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012 Mar 29;366(13):1190-9. doi: 10.1056/NEJMoa1109997.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose for this study is to help answer the following research questions\n\n* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.\n* Whether ixekizumab can help participants with Psoriasis.\n* How much ixekizumab should be given to participants.', 'detailedDescription': 'The study is a Phase 2 study with 3 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design, Part B is an optional, open label extension design and Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks). Approximately 125 participants will be randomized to 1 of 4 ixekizumab groups or to placebo (approximately 25 participants per group) in Part A. Participants will be evaluated for treatment efficacy and the primary endpoint will be evaluated at week 12. Between week 20 and week 32, participants with a less than 75% improvement in their Psoriasis Area and Severity Index (PASI) score compared to baseline will be eligible to begin Part B. Participants in Part B will receive subcutaneous (SC) injections of ixekizumab 120 milligrams (mg) every 4 weeks through week 236. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Participants in Part C may receive SC injections of ixekizumab 80 mg every 4 weeks for up to an additional 104 weeks through approximately week 340. Participants who complete Part A, Part B, and Part C will have a total study participation of approximately 344 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria Common to Both Part A:\n\n* Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.\n* Participant is a candidate for systemic therapy\n* Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization\n\nInclusion Criterion Specific to Part B\n\n* Participant has completed the treatment period for part A (at least through week 20)\n\nInclusion Criterion Specific to Part C\n\n* Participant has completed the treatment period for part B\n\nExclusion Criteria Common to Part A, B and C:\n\n* Participant has pustular, erythrodermic and/or guttate forms of psoriasis\n* Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry\n* Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \\>28 days, infliximab or adalimumab \\>56 days, alefacept \\>60 days, ustekinumab \\>8 months, or any other biologic agent/monoclonal antibody \\>5 half-lives prior to baseline\n* Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \\[PUVA\\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 \\[mild, such as desonide\\] or 7 \\[least potent, such as hydrocortisone\\] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)\n* Participant has donated more than 500 mL of blood within the last month\n* Participant has another serious disorder or illness\n* Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months\n* Participant has a history of uncontrolled high blood pressure\n* Participant has clinical laboratory test results at entry that are outside the normal reference range\n* Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug\n* Participant is a woman who is lactating or breast feeding\n* If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study\n* If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months\n* If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate\n* If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study\n\nExclusion Criteria Specific to B:\n\n* If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab\n* If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant.\n\nExclusion Criteria Specific to C:\n\n* If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab\n* If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant."}, 'identificationModule': {'nctId': 'NCT01107457', 'briefTitle': 'A Study in Participants With Moderate to Severe Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis', 'orgStudyIdInfo': {'id': '12060'}, 'secondaryIdInfos': [{'id': 'I1F-MC-RHAJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg Ixekizumab', 'description': 'Part A:\n\n10 milligrams (mg) ixekizumab given subcutaneous (SC) on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}, {'type': 'EXPERIMENTAL', 'label': '25 mg Ixekizumab', 'description': 'Part A:\n\n25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}, {'type': 'EXPERIMENTAL', 'label': '75 mg Ixekizumab', 'description': 'Part A:\n\n75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\n120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}, {'type': 'EXPERIMENTAL', 'label': '150 mg Ixekizumab', 'description': 'Part A:\n\n150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional)\n\nAdministered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part A:\n\nPlacebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.\n\nPart B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.\n\nPart C: (optional)\n\n80 mg ixekizumab given SC Q4W through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '120 mg Ixekizumab', 'description': 'Part B: (optional)\n\n120 mg ixekizumab given SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.\n\nPart C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}, {'type': 'EXPERIMENTAL', 'label': '80 mg Ixekizumab', 'description': 'Part B: (optional)\n\nSubsequent to an amendment on May 2012, administration changed to 80 mg ixekizumab Q4W through Week 236.\n\nPart C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.', 'interventionNames': ['Biological: Ixekizumab']}], 'interventions': [{'name': 'Ixekizumab', 'type': 'BIOLOGICAL', 'otherNames': ['LY2439821'], 'description': 'Administered subcutaneously', 'armGroupLabels': ['10 mg Ixekizumab', '120 mg Ixekizumab', '150 mg Ixekizumab', '25 mg Ixekizumab', '75 mg Ixekizumab', '80 mg Ixekizumab', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '60118', 'city': 'West Dundee', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.09808, 'lon': -88.28286}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '11418', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}