Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT02394561
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks', 'description': 'Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Cw6-Negative AIN457 300 mg', 'description': 'Cw6-Negative AIN457 300 mg', 'otherNumAtRisk': 246, 'deathsNumAtRisk': 246, 'otherNumAffected': 14, 'seriousNumAtRisk': 246, 'deathsNumAffected': 2, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Cw6-Positive AIN457 300 mg', 'description': 'Cw6-Positive AIN457 300 mg', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 20, 'seriousNumAtRisk': 185, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatic lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Enthesopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Meniscal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Scrotal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory tract irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '85.9'}, {'value': '81.7', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '86.3'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '6.2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \\< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 16 weeks', 'description': 'PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '430', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG002', 'title': 'Difference in % (Cw6-pos vs Cw6-neg)', 'description': 'Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.'}], 'classes': [{'title': 'W1 IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '418', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '5.65'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '4.79'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '-2.86', 'upperLimit': '3.75'}]}]}, {'title': 'W1 PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '8.78', 'upperLimit': '19.29'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '8.24', 'upperLimit': '16.89'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '-5.02', 'upperLimit': '8.09'}]}]}, {'title': 'W1 PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '5.62'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '2.30'}, {'value': '1.82', 'groupId': 'OG002', 'lowerLimit': '-0.52', 'upperLimit': '5.20'}]}]}, {'title': 'W2 IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '430', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.05', 'upperLimit': '13.74'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '4.08', 'upperLimit': '10.83'}, {'value': '1.79', 'groupId': 'OG002', 'lowerLimit': '-3.29', 'upperLimit': '7.36'}]}]}, {'title': 'W2 PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '430', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '36.73', 'upperLimit': '51.51'}, {'value': '44.5', 'groupId': 'OG001', 'lowerLimit': '38.16', 'upperLimit': '50.95'}, {'value': '-0.47', 'groupId': 'OG002', 'lowerLimit': '-9.84', 'upperLimit': '8.98'}]}]}, {'title': 'W2 PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '430', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '10.82', 'upperLimit': 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'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '93.86', 'upperLimit': '99.79'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.59', 'upperLimit': '99.61'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '-4.41', 'upperLimit': '3.88'}]}]}, {'title': 'WK48 PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '87.86', 'upperLimit': '97.52'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '85.67', 'upperLimit': '95.10'}, {'value': '2.72', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '8.98'}]}]}, {'title': 'WK48 PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '76.40', 'upperLimit': '90.45'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '73.48', 'upperLimit': '86.35'}, {'value': '3.84', 'groupId': 'OG002', 'lowerLimit': '-5.59', 'upperLimit': '12.64'}]}]}, {'title': 'WK48 PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '59.38', 'upperLimit': '77.02'}, {'value': '61.6', 'groupId': 'OG001', 'lowerLimit': '53.60', 'upperLimit': '69.23'}, {'value': '7.06', 'groupId': 'OG002', 'lowerLimit': '-4.44', 'upperLimit': '18.02'}]}]}, {'title': 'WK60 IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '78.21', 'upperLimit': '93.84'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '76.00', 'upperLimit': '90.02'}, {'value': '3.60', 'groupId': 'OG002', 'lowerLimit': '-6.97', 'upperLimit': '13.09'}]}]}, {'title': 'WK60 PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '89.43', 'upperLimit': '99.22'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '89.35', 'upperLimit': '98.13'}, {'value': '1.29', 'groupId': 'OG002', 'lowerLimit': '-5.94', 'upperLimit': '7.34'}]}]}, {'title': 'WK60 PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '81.24', 'upperLimit': '95.58'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '83.05', 'upperLimit': '94.68'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '-9.42', 'upperLimit': '8.37'}]}]}, {'title': 'WK60 PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '72.38', 'upperLimit': '90.09'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '66.01', 'upperLimit': '82.30'}, {'value': '7.71', 'groupId': 'OG002', 'lowerLimit': '-4.27', 'upperLimit': '18.58'}]}]}, {'title': 'WK60 PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '53.52', 'upperLimit': '75.33'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '46.91', 'upperLimit': '65.37'}, {'value': '8.70', 'groupId': 'OG002', 'lowerLimit': '-5.19', 'upperLimit': '21.80'}]}]}, {'title': 'WK72 IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '70.83', 'upperLimit': '94.43'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '67.67', 'upperLimit': '89.22'}, {'value': '5.37', 'groupId': 'OG002', 'lowerLimit': '-10.7', 'upperLimit': '19.47'}]}]}, {'title': 'WK72 PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '80.08', 'upperLimit': '98.46'}, {'value': '93.4', 'groupId': 'OG001', 'lowerLimit': '84.05', 'upperLimit': '98.18'}, {'value': '-0.76', 'groupId': 'OG002', 'lowerLimit': '-13.5', 'upperLimit': '9.55'}]}]}, {'title': 'WK72 PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '70.83', 'upperLimit': '94.43'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '77.78', 'upperLimit': '95.26'}, {'value': '-3.16', 'groupId': 'OG002', 'lowerLimit': '-18.1', 'upperLimit': '9.79'}]}]}, {'title': 'WK72 PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '59.70', 'upperLimit': '87.64'}, {'value': '73.8', 'groupId': 'OG001', 'lowerLimit': '60.93', 'upperLimit': '84.20'}, {'value': '1.84', 'groupId': 'OG002', 'lowerLimit': '-15.8', 'upperLimit': '17.98'}]}]}, {'title': 'WK72 PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '42.11', 'upperLimit': '73.68'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '37.70', 'upperLimit': '63.86'}, {'value': '7.72', 'groupId': 'OG002', 'lowerLimit': '-11.7', 'upperLimit': '26.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': "IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varied across visits'}, {'type': 'SECONDARY', 'title': 'Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'title': 'W1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '17.04', 'groupId': 'OG001'}]}]}, {'title': 'W2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '22.73', 'groupId': 'OG000'}, {'value': '-21.6', 'spread': '22.72', 'groupId': 'OG001'}]}]}, {'title': 'W3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.0', 'spread': '25.45', 'groupId': 'OG000'}, {'value': '-36.5', 'spread': '27.20', 'groupId': 'OG001'}]}]}, {'title': 'W4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-49.6', 'spread': '29.36', 'groupId': 'OG000'}, {'value': '-49.5', 'spread': '29.24', 'groupId': 'OG001'}]}]}, {'title': 'W8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-71.2', 'spread': '28.60', 'groupId': 'OG000'}, {'value': '-71.2', 'spread': '28.91', 'groupId': 'OG001'}]}]}, {'title': 'W12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-78.7', 'spread': '27.31', 'groupId': 'OG000'}, {'value': '-79.0', 'spread': '25.37', 'groupId': 'OG001'}]}]}, {'title': 'W16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-84.1', 'spread': '24.52', 'groupId': 'OG000'}, {'value': '-83.3', 'spread': '22.97', 'groupId': 'OG001'}]}]}, {'title': 'W20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85.3', 'spread': '24.26', 'groupId': 'OG000'}, {'value': '-84.5', 'spread': '23.80', 'groupId': 'OG001'}]}]}, {'title': 'W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-86.2', 'spread': '25.17', 'groupId': 'OG000'}, {'value': '-84.1', 'spread': '26.34', 'groupId': 'OG001'}]}]}, {'title': 'W36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-88.6', 'spread': '22.34', 'groupId': 'OG000'}, {'value': '-87.6', 'spread': '23.82', 'groupId': 'OG001'}]}]}, {'title': 'W48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-86.2', 'spread': '25.75', 'groupId': 'OG000'}, {'value': '-84.9', 'spread': '26.06', 'groupId': 'OG001'}]}]}, {'title': 'W60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-83.3', 'spread': '28.44', 'groupId': 'OG000'}, {'value': '-81.0', 'spread': '26.97', 'groupId': 'OG001'}]}]}, {'title': 'W72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-79.1', 'spread': '32.92', 'groupId': 'OG000'}, {'value': '-75.8', 'spread': '29.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': "IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients across visits varied'}, {'type': 'SECONDARY', 'title': 'Median Time to Reach PASI 90 and 75 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'title': 'PASI 90', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '89'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '92'}]}]}, {'title': 'PASI 75', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '57'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '57'}]}]}], 'analyses': [{'pValue': '0.1295', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'difference between cohorts for PASI 90 using Kaplan-Meier estimate'}, {'pValue': '0.4470', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'difference between cohorts for PASI 75 using Kaplan-Meier estimate', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Time in days to reach PASI scores of 90 and 75.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients in the Safety Set.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '6.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '7.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '7.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '6.70', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'At all time points'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to approximatly 72 weeks', 'description': "The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort", 'unitOfMeasure': 'numbers in a score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varied across visits. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on Quality of Life.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients in the Safety Set'}], 'classes': [{'title': 'W16 Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.37', 'groupId': 'OG000'}]}]}, {'title': 'W24 Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.38', 'groupId': 'OG000'}]}]}, {'title': 'W48 Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.67', 'groupId': 'OG000'}]}]}, {'title': 'W72 Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.44', 'groupId': 'OG000'}]}]}, {'title': 'W16 Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.19', 'groupId': 'OG000'}]}]}, {'title': 'W24 Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.22', 'groupId': 'OG000'}]}]}, {'title': 'W48 Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.31', 'groupId': 'OG000'}]}]}, {'title': 'W72 Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.19', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'pValueComment': 'All time points', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up approximately 72 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort', 'unitOfMeasure': 'numbers on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varies by visit. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.'}, {'type': 'SECONDARY', 'title': 'Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients in the Safety Set'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort', 'unitOfMeasure': 'numbers on scores', 'reportingStatus': 'POSTED', 'populationDescription': 'Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Mass Index (Safety Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.064', 'spread': '0.7748', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '0.9905', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.086', 'spread': '1.0213', 'groupId': 'OG000'}, {'value': '-0.071', 'spread': '1.2260', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.302', 'spread': '1.3474', 'groupId': 'OG000'}, {'value': '-0.052', 'spread': '1.4991', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.533', 'spread': '1.8101', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '1.8982', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varied across visits'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Waist Circumference (Safety Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '3.147', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '3.006', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '3.689', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '4.119', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'spread': '4.596', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '5.547', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.81', 'spread': '4.583', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '4.501', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varied across visits'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Weight (Safety Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'OG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '2.242', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '2.809', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '3.008', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '3.572', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '3.909', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '4.329', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '4.678', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '5.538', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients varied across visits'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'FG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}], 'periods': [{'title': 'CORE Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'ITT Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Five hundred thirty participants were screened and 434 entered the CORE Phase. However, there were 3 patients without Cw6 assessment which was necessary for stratification to the two arms, therefore 431 were considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'BG001', 'title': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.71', 'spread': '13.148', 'groupId': 'BG000'}, {'value': '47.18', 'spread': '12.919', 'groupId': 'BG001'}, {'value': '45.26', 'spread': '13.189', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Time since first diagnosis of psoriasis', 'classes': [{'categories': [{'measurements': [{'value': '19.63', 'spread': '12.489', 'groupId': 'BG000'}, {'value': '17.46', 'spread': '11.343', 'groupId': 'BG001'}, {'value': '18.39', 'spread': '11.883', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-22', 'size': 773685, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-07T10:02', 'hasProtocol': True}, {'date': '2017-09-20', 'size': 474724, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-07T10:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arms represent stratification of Cw6 positive and Cw6 negative patients'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 434}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2015-02-25', 'resultsFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-21', 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)', 'timeFrame': 'Baseline up to 16 weeks', 'description': 'PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.'}], 'secondaryOutcomes': [{'measure': 'Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': "IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0)."}, {'measure': 'Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': "IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe')."}, {'measure': 'Median Time to Reach PASI 90 and 75 (ITT)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Time in days to reach PASI scores of 90 and 75.'}, {'measure': 'Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)', 'timeFrame': 'Baseline up to approximatly 72 weeks', 'description': "The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort"}, {'measure': 'Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)', 'timeFrame': 'Baseline up approximately 72 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort'}, {'measure': 'Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort'}, {'measure': 'Changes From Baseline in Body Mass Index (Safety Set)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit'}, {'measure': 'Changes From Baseline in Waist Circumference (Safety Set)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit'}, {'measure': 'Changes From Baseline in Weight (Safety Set)', 'timeFrame': 'Baseline up to approximately 72 weeks', 'description': 'Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Type Psorisis']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis', 'detailedDescription': 'Biological agents represent the most advanced type of treatment for psoriasis. Secukinumab is a human monoclonal anti IL-17A antibody that binds to human IL-17A and neutralizes its bioactivity by inhibiting IL17A produced by both Th17 cells and those of the innate immune system, thus providing complete anti IL17A blockage. Targeting IL-17A has the potential to reduce autoimmune inflammation while leaving other immune functions undisturbed. While targeting of Th1-promoting or Th17-promoting cytokines affects critical mediators such as IFN-γ, IL-22 and IL-21, selective targeting of IL-17A leaves these Th1/17 activities, as well as certain protective functions of innate cells intact. Furthermore, as a fully human monoclonal antibody, secukinumab should reduce immunogenic risks compared to current or emerging antibody therapies that are not fully human.\n\nMany recent studies have shown that highly selective biologic drugs are not effective in every patient and that variations in the genome can be associated with different clinical responses or side effects to a given drug. The PSORS1 locus on chromosome 6p is generally understood to confer the most risk for psoriasis. A specific allele for this locus, HLA C\\*06, is present in about 60% of psoriatic patient cases. Data linking secukinumab efficacy to a particular genetic marker are lacking.\n\nRecent research has revealed a marked difference in the proportion of PASI 90 achievers at 12 weeks between Cw6-positive and Cw6-negative patients (85.7% vs 56.5%) treated with ustekinumab (Talamonti M et al. 2013) and a greater efficacy of anti-TNFα drugs in CW6 negative patients (Galli et al. 2013).Unlike anti-IL-12/23 agents, secukinumab inhibits IL-17 produced by both Th17 cells after presentation by antigen presenting cells (in this case Cw6) and cells of the innate immune system whose activation does not require antigen presentation. Providing a drug that is equally effective on both Cw6-negative and Cw6-positive patients would be an important clinical accomplishment and would eliminate the need for costly HLA-Cw6 tests. The choice of a cohort study would therefore seem appropriate for this clinical context.\n\nThe purpose of this study was to explore the different efficacy and safety profile of secukinumab 300 mg in patients with moderate to severe chronic plaque-type psoriasis, stratified for the presence of HLA-C\\*06, whose determination was blinded for patients and investigators. The study was conducted both on anti-TNFα-naïve and anti-TNFα failure patients and also stratified for TNFα - 308 polymorphism, BMI, smoking and metabolic syndrome, among others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.\n2. Men or women at least 18 years of age at time of screening.\n3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria \\[CASPAR\\]).\n4. Moderate to severe psoriasis as defined at enrollment by:\n\n * PASI score ≥ 10 or\n * PASI score \\> 5 but \\< 10 and DLQI ≥10\n5. Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).\n\nExclusion criteria\n\n1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).\n2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.\n3. Anti-TNFα therapy within timelines depending on drug half-life.\n4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.\n5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.\n6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.\n7. Ongoing use of corticosteroid topical treatments or UV therapy.'}, 'identificationModule': {'nctId': 'NCT02394561', 'acronym': 'SUPREME', 'briefTitle': 'A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)', 'orgStudyIdInfo': {'id': 'CAIN457AIT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cw6-positive AIN457 300 mg', 'description': 'Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cw6-negative AIN457 300 mg', 'description': 'Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks', 'interventionNames': ['Biological: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'BIOLOGICAL', 'otherNames': ['AIN457'], 'description': 'Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection', 'armGroupLabels': ['Cw6-negative AIN457 300 mg', 'Cw6-positive AIN457 300 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'state': '(MI)', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '60126', 'city': 'Ancona', 'state': 'AN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '67100', 'city': 'L’Aquila', 'state': 'AQ', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '70124', 'city': 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