Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02267135
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '+1 (800) 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 publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period 1 Secukinumab 300 mg', 'description': 'Treatment Period 1 Secukinumab 300 mg', 'otherNumAtRisk': 51, 'otherNumAffected': 8, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Period 1 Placebo', 'description': 'Treatment Period 1 Placebo', 'otherNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Treatment Period 2 Placebo/Secukinumab 300 mg', 'description': 'Treatment Period 2 Placebo/Secukinumab 300 mg', 'otherNumAtRisk': 46, 'otherNumAffected': 5, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Treatment Period 1 & 2: Any Secukinumab', 'otherNumAtRisk': 96, 'otherNumAffected': 5, 'seriousNumAtRisk': 96, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psoriasis Scalp Severity Index 90 (PSSI 90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51', 'ciLowerLimit': '37', 'ciUpperLimit': '65', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'adjusted for body weight (\\< 90 kg, ≥ 90 kg)'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis\n\nPercentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': "Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PSSI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.47', 'spread': '17.052', 'groupId': 'OG000'}, {'value': '-5.98', 'spread': '12.868', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Scalp Severity Index 75 (PSSI 75) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Scalp Severity Index 100 (PSSI 100) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to 50% Reduction in PSSI Score up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '8.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm\n\nThe median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index 75 (PASI 75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index 90 (PASI 90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index 100 (PASI 100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '3.233', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '2.615', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Pain\n\nScale of 0-10 with 10 being the most painful', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Assessment of Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.10', 'spread': '3.008', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '2.840', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Itching\n\nScale of 0-10 with 10 being the most itchy', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Assessment of Scaling (Scalp Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.24', 'spread': '2.861', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '2.763', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Scaling (scalp only)\n\nScale of 0-10 with 10 being the most scaling', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}], 'periods': [{'title': 'Period 1 (Randomized Set)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2 (Randomized Set)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Secukinumab', 'description': 'Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Mean', 'categories': [{'measurements': [{'value': '42.7', 'spread': '13.39', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '68'}, {'value': '41.1', 'spread': '14.17', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '69'}, {'value': '41.9', 'spread': '13.74', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Age (years)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2014-09-30', 'resultsFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-26', 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Scalp Severity Index 90 (PSSI 90)', 'timeFrame': '12 weeks', 'description': 'PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis\n\nPercentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"'}], 'secondaryOutcomes': [{'measure': "Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)", 'timeFrame': '12 weeks', 'description': 'IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis'}, {'measure': 'Change From Baseline in PSSI Score', 'timeFrame': '12 weeks', 'description': 'Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe'}, {'measure': 'Psoriasis Scalp Severity Index 75 (PSSI 75) Response', 'timeFrame': '12 weeks', 'description': 'PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis'}, {'measure': 'Psoriasis Scalp Severity Index 100 (PSSI 100) Response', 'timeFrame': '12 weeks', 'description': 'PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis'}, {'measure': 'Time to 50% Reduction in PSSI Score up to Week 12', 'timeFrame': '12 weeks', 'description': 'Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm\n\nThe median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo'}, {'measure': 'Psoriasis Area and Severity Index 75 (PASI 75)', 'timeFrame': '12 weeks', 'description': 'PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis'}, {'measure': 'Psoriasis Area and Severity Index 90 (PASI 90)', 'timeFrame': '12 weeks', 'description': 'PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis'}, {'measure': 'Psoriasis Area and Severity Index 100 (PASI 100)', 'timeFrame': '12 weeks', 'description': 'PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis'}, {'measure': "Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)", 'timeFrame': '12 weeks', 'description': 'IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis'}, {'measure': 'Change From Baseline in Subject Assessment of Pain', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Pain\n\nScale of 0-10 with 10 being the most painful'}, {'measure': 'Change From Baseline in Subject Assessment of Itching', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Itching\n\nScale of 0-10 with 10 being the most itchy'}, {'measure': 'Change From Baseline in Subject Assessment of Scaling (Scalp Only)', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the Subject Assessment of Scaling (scalp only)\n\nScale of 0-10 with 10 being the most scaling'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A'], 'conditions': ['Chronic Scalp Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=38', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic scalp psoriasis for at least the previous six months\n* Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected\n* Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.\n\nExclusion Criteria:\n\n* Forms of psoriasis other than chronic plaque\n* Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)\n* Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)\n* Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors\n* Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer\n* Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab\n* Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02267135', 'acronym': 'SCALP', 'briefTitle': 'Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis', 'orgStudyIdInfo': {'id': 'CAIN457AUS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secukinumab', 'description': 'Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive', 'interventionNames': ['Biological: Secukinumab 300 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Secukinumab 300 mg', 'type': 'BIOLOGICAL', 'otherNames': ['AIN457 300 mg'], 'description': 'Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.', 'armGroupLabels': ['Secukinumab']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43230', 'city': 'Gahanna', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.01923, 'lon': -82.87934}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15213-3403', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}