Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 5:23 AM
Study NCT ID:
NCT01807520
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, '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': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The overall study completed. However, in Spain, the study terminated early in accordance with study protocol amendment 1.'}}, 'adverseEventsModule': {'timeFrame': 'up to week 140', 'eventGroups': [{'id': 'EG000', 'title': 'Any AIN457 150 mg', 'description': 'Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2', 'otherNumAtRisk': 96, 'otherNumAffected': 76, 'seriousNumAtRisk': 96, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Any AIN457 300 mg', 'description': 'Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2', 'otherNumAtRisk': 94, 'otherNumAffected': 79, 'seriousNumAtRisk': 94, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants who received placebo during treatment period 1', 'otherNumAtRisk': 65, 'otherNumAffected': 37, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Any AIN457 Dose', 'description': 'Participants who received AIN457 150 mg or AIN457 300 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'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eczema impetiginous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Erythrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received placebo during treatment period 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.4', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '-46.1', 'spread': '3.43', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '4.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.7', 'ciLowerLimit': '-39.1', 'ciUpperLimit': '-14.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.26', 'statisticalMethod': 'Mixed model reapeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.4', 'ciLowerLimit': '-45.2', 'ciUpperLimit': '-23.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.47', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': 'The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NAPSI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG002', 'title': 'Placebo - AIN457 150 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG003', 'title': 'Placebo - AIN457 300 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-37.9', 'spread': '37.32', 'groupId': 'OG000'}, {'value': '-45.3', 'spread': '27.22', 'groupId': 'OG001'}, {'value': '-15.4', 'spread': '32.79', 'groupId': 'OG002'}, {'value': '-7.8', 'spread': '31.77', 'groupId': 'OG003'}]}]}, {'title': 'Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-52.9', 'spread': '42.90', 'groupId': 'OG000'}, {'value': '-70.5', 'spread': '29.2', 'groupId': 'OG001'}, {'value': '-62.9', 'spread': '29.05', 'groupId': 'OG002'}, {'value': '-72.7', 'spread': '22.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 16 weeks, 132 weeks', 'description': 'The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the full analysis set (FAS) who had values at both baseline and the post-baseline time point, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}], 'classes': [{'title': 'Week 16, PASI 75', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16, IGA 0/1', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 132, PASI 75', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '82.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 132, IGA 0/1', 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks, 132 weeks', 'description': "PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS, who had evaluable data at a given time point, were analyzed for that time point. The FAS consisted of all randomized participants to whom treatment was assigned. Multiple imputation was applied where the number of evaluable participants was based on a rounded mean number of responders for 500 imputations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Develop Immunogenicity Against Secukinumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG002', 'title': 'Placebo - AIN457 150 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'OG003', 'title': 'Placebo - AIN457 300 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 132', 'description': 'The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set was analyzed. The safety set included all participants who took at least one dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'FG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants who received placebo during treatment period 1'}, {'id': 'FG003', 'title': 'Placebo - AIN457 150 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'FG004', 'title': 'Placebo - AIN457 300 mg', 'description': 'Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'FG005', 'title': 'Any AIN457 150 mg', 'description': 'Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2'}, {'id': 'FG006', 'title': 'Any AIN457 300 mg', 'description': 'Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2'}], 'periods': [{'title': 'Treatment Period 1 (0-16 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (16-132 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Non-compliant with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period (132-140 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'These participants discontinued from Treatment Period 1.', 'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'These participants received AIN457150mg during treatment period 1 and/or treatment period 2.', 'groupId': 'FG005', 'numSubjects': '81'}, {'comment': 'These participants received AIN457 300mg during treatment period 1 and/or treatment period 2.', 'groupId': 'FG006', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '77'}, {'groupId': 'FG006', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was made up of 4 periods: screening, treatment period 1, treatment period 2 and post-treatment follow-up.', 'preAssignmentDetails': 'In treatment period 1, participants were randomized in a 1:1:1 ratio to secukinumab 150mg, secukinumab 300mg or placebo. In treatment period 2, placebo participants were re-randomized in a 1:1 ratio to secukinumab 150mg or secukinumab 300mg. The follow-up period occurred 8 weeks post treatment period 2 (12 weeks post the last dose of secukinumab).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN457 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'BG001', 'title': 'AIN457 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants who received placebo during treatment period 1'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '10.94', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '44.1', 'spread': '11.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2013-01-23', 'resultsFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-14', 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment', 'timeFrame': 'Baseline, 16 weeks', 'description': 'The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in NAPSI Score', 'timeFrame': 'baseline, 16 weeks, 132 weeks', 'description': 'The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.'}, {'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132', 'timeFrame': '16 weeks, 132 weeks', 'description': "PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline."}, {'measure': 'Number of Participants Who Develop Immunogenicity Against Secukinumab', 'timeFrame': 'Week 132', 'description': 'The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate nail psoriasis', 'Severe nail psoriasis', 'psoriasis', 'Secukinumab'], 'conditions': ['Moderate to Severe Nail Psoriasis']}, 'descriptionModule': {'briefSummary': 'This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%\n* Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy\n\nExclusion Criteria:\n\n* Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)\n* Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)\n* Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects\n* Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply\n* Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor\n* Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer\n* History of hypersensitivity to constituents of the study treatment\n* Other protocol-defined inclusion/exclusion criteria do apply'}, 'identificationModule': {'nctId': 'NCT01807520', 'acronym': 'TRANSFIGURE', 'briefTitle': 'Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Nail Psoriasis', 'orgStudyIdInfo': {'id': 'CAIN457A2313'}, 'secondaryIdInfos': [{'id': '2012-005413-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secukinumab (AIN457) 150 mg', 'description': 'Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Secukinumab (AIN457) 300 mg', 'description': 'Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Secukinumab', 'type': 'BIOLOGICAL', 'otherNames': ['AIN457'], 'description': 'Study treatment was provided in pre-filled 1 mL syringes.', 'armGroupLabels': ['Secukinumab (AIN457) 150 mg', 'Secukinumab (AIN457) 300 mg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['placebo secukinumab'], 'description': 'Placebo was provided in pre-filled 1 mL syringes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '60077', 'city': 'Skokie', 'state': 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