Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-03 @ 7:20 AM
Study NCT ID:
NCT01624233
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Japanese Participants With Moderate-to-Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549079', 'term': 'ixekizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'LY2439821 80mg-Combined Induction and Maintenance Periods', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.', 'otherNumAtRisk': 91, 'otherNumAffected': 61, 'seriousNumAtRisk': 91, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'LY2439821 80mg-Drug-Free Period', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.', 'otherNumAtRisk': 70, 'otherNumAffected': 18, 'seriousNumAtRisk': 70, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'LY2439821 80mg-Retreatment Period', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.', 'otherNumAtRisk': 80, 'otherNumAffected': 52, 'seriousNumAtRisk': 80, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'LY2439821 80mg-Post-Treatment Follow-Up Period', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.', 'otherNumAtRisk': 88, 'otherNumAffected': 2, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 45, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 48, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 28, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperplastic cholecystopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week (Wk) 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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ≥75% Improvement in PASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 24', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wks 24 and 52', '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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W) Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.63', 'spread': '43.6', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W) Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.48', 'spread': '65.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)', 'description': 'PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.', 'unitOfMeasure': 'micrograms/milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Ixekizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Plaque Ps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Erythrodermic Ps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pustular Ps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Wk 52', 'description': 'Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving PASI 90% and 100% Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W) PASI 90%', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Wk 12 (80 mg Q2W) PASI 100%', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W) PASI 90%', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W) PASI 100%', 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W) PASI 90%', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W) PASI 100%', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wks 12, 24 and 52', '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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W) sPGA (0 or 1)', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W) sPGA (0 or 1)', 'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W) sPGA (0 or 1)', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Wk 12 (80 mg Q2W) sPGA (0)', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W) sPGA (0)', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W) sPGA (0)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wks 12, 24 and 52', 'description': "The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent of Body Surface Area (BSA) Involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-38.3', 'spread': '19.26', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-41.2', 'spread': '20.23', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-40.8', 'spread': '19.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).', 'unitOfMeasure': 'percentage of BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nail Psoriasis Severity Index (NAPSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '14.65', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-20.5', 'spread': '19.42', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-23.4', 'spread': '23.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Scalp Severity Index (PSSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-24.8', 'spread': '15.12', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-24.9', 'spread': '15.11', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-23.3', 'spread': '16.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '3.80', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 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\\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Numeric Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '2.68', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '2.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': "The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '6.57', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '6.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Wk 24 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wks 12, 24 and 52', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 12 (80 mg Q2W)', 'categories': [{'measurements': [{'value': '-47.3', 'spread': '22.05', 'groupId': 'OG000'}]}]}, {'title': 'Wk 52 (80 mg Q4W)', 'categories': [{'measurements': [{'value': '-51.0', 'spread': '19.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 52', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-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 0 mm (no pain) to 100 mm (pain as severe as you can imagine).", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).\n\nPeriod 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 100, PASI 75', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Wk 100, PASI 90', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 100, PASI 100', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192, PASI 75', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192, PASI 90', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192, PASI 100', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wk 100 and Retreatment Wk 192', '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: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With sPGA (0 or 1) and sPGA (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 100, sPGA(0, 1)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Wk 100, sPGA(0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192, sPGA(0, 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192, sPGA(0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Wk 100 and Retreatment Wk 192', 'description': "The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent of BSA Involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-24.7', 'spread': '17.32', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-40.2', 'spread': '21.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).', 'unitOfMeasure': 'percentage of BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing BSA at Wks 100 and 192 were imputed by last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NAPSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-16.8', 'spread': '19.87', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-21.4', 'spread': '26.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing NAPSI at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PSSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-8.5', 'spread': '16.16', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-23.2', 'spread': '15.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing PSSI at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QIDS-SR16 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.02', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 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\\] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing QIDS-SR16 at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '2.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': "The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Itch NRS at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DLQI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.83', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-8.9', 'spread': '5.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing DLQI at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participants Assessment of Joint Pain VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Baseline, Wk 100', 'categories': [{'measurements': [{'value': '-12.8', 'spread': '39.59', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Wk 192', 'categories': [{'measurements': [{'value': '-43.8', 'spread': '25.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-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).", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Joint Pain VAS at Wks 100 and 192 were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ACR20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'classes': [{'title': 'Wk 100', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wk 192', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Wk 100 and Wk Retreatment Wk 192', 'description': "ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.\n\nAnalysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).\n\nPeriod 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.'}], 'periods': [{'title': 'Period 2 - Induction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'Erythrodermic Psoriasis (Ps)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Pustular Ps', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Plaque Ps', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Period 3 - Maintenance', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Period 4 - Drug Free Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only responders in participants with plaque Ps moved to the Drug Free Period 4.', 'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'Adverse Event', 'achievements': [{'comment': '1 participant who discontinued due to adverse event is included in the participants who relapsed.', 'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'achievements': [{'comment': '1 participant who discontinued due to physician decision is included in the participants relapsed.', 'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Relapsed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}]}, {'title': 'Period 5 - Retreatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Period 5 included (participants with erythrodermic Ps or pustular Ps) or Period 4 completers.', 'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}, {'title': 'Period 6: Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Period 6 included participants received a dose of drug and exhibited the required neutrophil count.', 'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Period 2-Induction Dosing Period (Weeks 0 up to 12), Period 3-Maintenance Dosing Period (Weeks 12 up to 52), Period 4-Drug Free Period (Weeks 52 up to 100), Period 5-Retreatment Period (up to 192 additional weeks) and Period 6-Post-Treatment Follow-Up Period up to 12 weeks after the last visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '80 mg Ixekizumab (LY2439821)', 'description': 'Ixekizumab:\n\nPeriod 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).\n\nPeriod 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'spread': '11.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psoriasis Area and Severity Index (PASI) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.24', 'spread': '10.545', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', '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(no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Overall scores range from 0 (no Ps) to 72 (the most severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Static Physician Global Assessment (sPGA) Score', 'classes': [{'title': '0: Clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '1: Minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '2: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '3: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '4: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': '5: Very Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5).", 'unitOfMeasure': 'participants'}, {'title': 'Percentage (%) of Body Surface Area (BSA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45.5', 'spread': '23.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participant's hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nail Psoriasis Severity Index (NAPSI) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.1', 'spread': '22.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The NAPSI scale evaluates Ps severity in the fingernail bed and fingernail matrix with each divided into quadrants. Scores range from 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80. Higher scores indicate more severe Ps.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants with non-missing data were included.'}, {'title': 'Psoriasis Scalp Severity Index (PSSI) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '15.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants with non-missing data were included.'}, {'title': 'Quick Inventory of Depressive Symptomatology-Self Reported 16 Items(QIDS-SR16) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '4.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'QIDS-SR16 is a participant-administered, 16-item instrument assesses the existence and severity of symptoms of depression. A participant is asked a statement relating to the way they have felt for the past 7 days and rate on a 4-point scale: 0 (best) to 3 (worst). The sum of the domains \\[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite/weight, and psychomotor agitation/retardation\\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Itch Numeric Rating Scale (NRS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quick Inventory of Depressive Symptomatology-Self Reported (DLQI) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '6.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Joint Pain Visual Analog Scale (VAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '23.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-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 0 mm (no pain) to 100 mm (pain as severe as you can imagine).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants with non-missing data were included.'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'dispFirstSubmitDate': '2014-04-25', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2012-06-18', 'dispFirstSubmitQcDate': '2014-04-25', 'resultsFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2012-06-19', 'dispFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-15', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)', 'timeFrame': 'Week (Wk) 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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving ≥75% Improvement in PASI', 'timeFrame': 'Wks 24 and 52', '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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).'}, {'measure': 'Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab', 'timeFrame': 'Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)', 'description': 'PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.'}, {'measure': 'Number of Participants With Anti-Ixekizumab Antibodies', 'timeFrame': 'Baseline through Wk 52', 'description': 'Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.'}, {'measure': 'Percent of Participants Achieving PASI 90% and 100% Improvement', 'timeFrame': 'Wks 12, 24 and 52', '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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).'}, {'measure': 'Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)', 'timeFrame': 'Wks 12, 24 and 52', 'description': "The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal)."}, {'measure': 'Change From Baseline in Percent of Body Surface Area (BSA) Involvement', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).'}, {'measure': 'Change From Baseline in Nail Psoriasis Severity Index (NAPSI)', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.'}, {'measure': 'Change From Baseline in Psoriasis Scalp Severity Index (PSSI)', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.'}, {'measure': 'Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 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\\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.'}, {'measure': 'Change From Baseline in Itch Numeric Rating Scale (NRS) Score', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': "The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours."}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52', 'description': 'DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.'}, {'measure': 'Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]', 'timeFrame': 'Wks 12, 24 and 52', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR)."}, {'measure': 'Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)', 'timeFrame': 'Baseline, Wk 12; Baseline, Wk 52', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-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 0 mm (no pain) to 100 mm (pain as severe as you can imagine)."}, {'measure': 'Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement', 'timeFrame': 'Wk 100 and Retreatment Wk 192', '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: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=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 Ps) to 72 (the most severe disease).'}, {'measure': 'Percentage of Participants With sPGA (0 or 1) and sPGA (0)', 'timeFrame': 'Wk 100 and Retreatment Wk 192', 'description': "The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal)."}, {'measure': 'Change From Baseline in Percent of BSA Involvement', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).'}, {'measure': 'Change From Baseline in NAPSI', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.'}, {'measure': 'Change From Baseline in PSSI', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.'}, {'measure': 'Change From Baseline in QIDS-SR16 Score', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 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\\] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.'}, {'measure': 'Change From Baseline in Itch NRS Score', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': "The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours."}, {'measure': 'Change From Baseline in DLQI Score', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': 'DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.'}, {'measure': 'Change From Baseline in Participants Assessment of Joint Pain VAS', 'timeFrame': 'Baseline, Wk 100; Baseline, Retreatment Wk 192', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-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)."}, {'measure': 'Number of Participants Achieving ACR20', 'timeFrame': 'Wk 100 and Wk Retreatment Wk 192', 'description': "ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.\n\nAnalysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '32910360', 'type': 'DERIVED', 'citation': 'Honma M, Cai Z, Burge R, Zhu B, Yotsukura S, Torisu-Itakura H. Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J). Dermatol Ther (Heidelb). 2020 Dec;10(6):1397-1404. doi: 10.1007/s13555-020-00441-4. Epub 2020 Sep 10.'}, {'pmid': '25355284', 'type': 'DERIVED', 'citation': 'Saeki H, Nakagawa H, Ishii T, Morisaki Y, Aoki T, Berclaz PY, Heffernan M. Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1148-55. doi: 10.1111/jdv.12773. Epub 2014 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men must agree to use a reliable method of birth control during the study\n* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment\n* Candidates for phototherapy and/or systemic therapy\n* Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment\n* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis\n* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis\n\nExclusion Criteria:\n\n* History of drug-induced psoriasis\n* Concurrent or recent use of any biologic agent\n* Received systemic psoriasis therapy \\[such as psoralen and ultraviolet A (PUVA) light therapy\\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis\n* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study\n* Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab\n* Serious disorder or illness other than psoriasis\n* Serious infection within the last 3 months\n* Breastfeeding or nursing (lactating) women\n* Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis'}, 'identificationModule': {'nctId': 'NCT01624233', 'acronym': 'UNCOVER-J', 'briefTitle': 'A Study in Japanese Participants With Moderate-to-Severe Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis', 'orgStudyIdInfo': {'id': '13976'}, 'secondaryIdInfos': [{'id': 'I1F-JE-RHAT', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '80 mg ixekizumab', 'description': 'Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.', 'interventionNames': ['Drug: 80 mg ixekizumab']}], 'interventions': [{'name': '80 mg ixekizumab', 'type': 'DRUG', 'otherNames': ['LY2439821'], 'description': 'Administered SC', 'armGroupLabels': ['80 mg ixekizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '791-0295', 'city': 'Ehime', 'country': 'Japan', '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.'}, {'zip': '830-0011', 'city': 'Fukuoka', 'country': 'Japan', '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': 33.6, 'lon': 130.41667}}, {'zip': '501-1194', 'city': 'Gifu', 'country': 'Japan', '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': 35.42291, 'lon': 136.76039}}, {'zip': '060-0814', 'city': 'Hokkaido', 'country': 'Japan', '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.'}, {'zip': '514-8507', 'city': 'Hyōgo', 'country': 'Japan', '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': 43.36667, 'lon': 144.43333}}, {'zip': '920-8641', 'city': 'Ishikawa', 'country': 'Japan', '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': 26.42333, 'lon': 127.82139}}, {'zip': '259-1193', 'city': 'Kanagawa', 'country': 'Japan', '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': 37.58333, 'lon': 139.91667}}, {'zip': '860-0811', 'city': 'Kumamoto', 'country': 'Japan', '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': 32.80589, 'lon': 130.69181}}, {'zip': '606-8397', 'city': 'Kyoto', 'country': 'Japan', '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': 35.02107, 'lon': 135.75385}}, {'zip': '889-1692', 'city': 'Miyazaki', 'country': 'Japan', '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': 31.91667, 'lon': 131.41667}}, {'zip': '390-8621', 'city': 'Nagano', 'country': 'Japan', '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': 36.65, 'lon': 138.18333}}, {'zip': '020-8505', 'city': 'Numakunai', 'country': 'Japan', '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': 39.96667, 'lon': 141.21667}}, {'zip': '700-8558', 'city': 'Okayama', 'country': 'Japan', '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': 34.65, 'lon': 133.93333}}, {'zip': '565-0871', 'city': 'Osaka', 'country': 'Japan', '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': 34.69379, 'lon': 135.50107}}, {'zip': '589', 'city': 'Osaka-Pref', 'country': 'Japan', '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.'}, {'zip': '350-0495', 'city': 'Saitama', 'country': 'Japan', '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': 35.90807, 'lon': 139.65657}}, {'zip': '162-8666', 'city': 'Tokyo', 'country': 'Japan', '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': 35.6895, 'lon': 139.69171}}], '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'}}}}