Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02762994
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nikiforovaan@biocad.ru', 'phone': '+7(812) 380 49 33', 'title': 'Nikiforova Aleksandra', 'phoneExt': '6254', 'organization': 'BIOCAD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 month', 'description': 'The safety analysis included the data from all patients received at least one dose of BCD-085/placebo. 3 patients were removed from the safety analysis because they recalled their informed consent before the first dose.\n\nAggravation, worsening, and symptoms of the plaque psoriasis were not reportable as AEs. If hospitalization was due to aggravation or worsening of psoriasis it was not reportable as an SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 14, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 11, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ARVI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ESR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial BP increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systolic BP increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LDH increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With PASI 75 Response After 12 Weeks of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 8', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Proportion of PASI 50 achievers, Week 4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Proportion of PASI 50 achievers,Week 8', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Proportion of PASI 50 achievers,Week 12', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Proportion of PASI 90 achievers, Week 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Proportion of PASI 90 achievers, Week 8', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Proportion of PASI 90 achievers, Week 12', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Mean percentage change from baseline in PASI score at Week 4', 'categories': [{'measurements': [{'value': '61.309', 'spread': '23.423', 'groupId': 'OG000'}, {'value': '58.855', 'spread': '27.382', 'groupId': 'OG001'}, {'value': '59.524', 'spread': '26.251', 'groupId': 'OG002'}, {'value': '26.277', 'spread': '25.933', 'groupId': 'OG003'}]}]}, {'title': 'Mean percentage change from baseline in PASI score at Week 8', 'categories': [{'measurements': [{'value': '82.148', 'spread': '17.751', 'groupId': 'OG000'}, {'value': '78.883', 'spread': '20.350', 'groupId': 'OG001'}, {'value': '85.012', 'spread': '16.389', 'groupId': 'OG002'}, {'value': '36.512', 'spread': '29.541', 'groupId': 'OG003'}]}]}, {'title': 'Mean percentage change from baseline in PASI score at Week 12', 'categories': [{'measurements': [{'value': '88.698', 'spread': '15.670', 'groupId': 'OG000'}, {'value': '88.682', 'spread': '13.607', 'groupId': 'OG001'}, {'value': '92.771', 'spread': '11.426', 'groupId': 'OG002'}, {'value': '45.495', 'spread': '36.892', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease).\n\nRelative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Mean percentage change from baseline in BSA at Week 4', 'categories': [{'measurements': [{'value': '43.046', 'spread': '31.699', 'groupId': 'OG000'}, {'value': '45.610', 'spread': '30.987', 'groupId': 'OG001'}, {'value': '39.948', 'spread': '35.084', 'groupId': 'OG002'}, {'value': '13.692', 'spread': '22.333', 'groupId': 'OG003'}]}]}, {'title': 'Mean percentage change from baseline in BSA at Week 8', 'categories': [{'measurements': [{'value': '70.479', 'spread': '29.547', 'groupId': 'OG000'}, {'value': '67.233', 'spread': '30.765', 'groupId': 'OG001'}, {'value': '68.516', 'spread': '33.657', 'groupId': 'OG002'}, {'value': '24.075', 'spread': '32.046', 'groupId': 'OG003'}]}]}, {'title': 'Mean percentage change from baseline in BSA at Week 12', 'categories': [{'measurements': [{'value': '82.888', 'spread': '24.699', 'groupId': 'OG000'}, {'value': '82.811', 'spread': '19.751', 'groupId': 'OG001'}, {'value': '82.074', 'spread': '29.460', 'groupId': 'OG002'}, {'value': '36.912', 'spread': '39.447', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The area of skin affected by psoriasis (BSA) is estimated with the palm rule. The area of the human palm without fingers corresponds to about 1% of the body surface.\n\nRelative (percentage) from baseline is calculated as "100 x (baseline value - time point t value) / (baseline value)". If the value decreases from baseline it means improvement.', 'unitOfMeasure': 'percentage of BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25.204', 'spread': '45.347', 'groupId': 'OG000'}, {'value': '47.095', 'spread': '29.800', 'groupId': 'OG001'}, {'value': '66.370', 'spread': '29.455', 'groupId': 'OG002'}, {'value': '7.828', 'spread': '36.243', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The NAPSI is used to assign a score to each nail involved, which can vary from 0 to 8. In this study, nail involvement will be assessed only for hands, so the total index of all nails can be from 0 to 80 (only hands). A negative change from baseline indicates improvement.\n\nRelative (percentage) change in NAPSI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis did not include patients who had no nail psoriasis at baseline and who had no worsening of nail psoriasis during the study (patients who had NAPSI = 0 at baseline and at Week 12). The final population for NAPSI assessment comprised 66 patients.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Changes in the intensity of pruritus, Week 1', 'categories': [{'measurements': [{'value': '-19.600', 'spread': '23.562', 'groupId': 'OG000'}, {'value': '-25.367', 'spread': '29.678', 'groupId': 'OG001'}, {'value': '-26.071', 'spread': '29.034', 'groupId': 'OG002'}, {'value': '-14.269', 'spread': '34.582', 'groupId': 'OG003'}]}]}, {'title': 'Changes in the intensity of pruritus, Week 4', 'categories': [{'measurements': [{'value': '-34.767', 'spread': '24.996', 'groupId': 'OG000'}, {'value': '-33.700', 'spread': '31.682', 'groupId': 'OG001'}, {'value': '-43.214', 'spread': '30.927', 'groupId': 'OG002'}, {'value': '-13.269', 'spread': '32.863', 'groupId': 'OG003'}]}]}, {'title': 'Changes in the intensity of pruritus, Week 8', 'categories': [{'measurements': [{'value': '-38.533', 'spread': '25.871', 'groupId': 'OG000'}, {'value': '-35.633', 'spread': '34.927', 'groupId': 'OG001'}, {'value': '-47.304', 'spread': '33.431', 'groupId': 'OG002'}, {'value': '-15.538', 'spread': '34.195', 'groupId': 'OG003'}]}]}, {'title': 'Changes in the intensity of pruritus, Week 12', 'categories': [{'measurements': [{'value': '-39.533', 'spread': '26.432', 'groupId': 'OG000'}, {'value': '-40.700', 'spread': '30.563', 'groupId': 'OG001'}, {'value': '-48.214', 'spread': '30.839', 'groupId': 'OG002'}, {'value': '-18.269', 'spread': '34.898', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 4, Week 8, Week 12', 'description': 'Mean change in severity of pruritus assessed by visual analog scale (from 0 (no itch) to 100 mm (unbearable itch)) after 1, 4, 8 and 12 weeks of treatment with BCD-085', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'sPGA score 0 or 1, Week 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'sPGA score 0 or 1, Week 8', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'sPGA score 0 or 1, Week 12', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The sPGA scale is used to assess the psoriatic lesions in a certain patient from 0 (clear) to 5 (very severe). Within each area, the severity is estimated by three criteria (induration, desquamation, and erythema).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Changes of the PH score from baseline, Week 4', 'categories': [{'measurements': [{'value': '3.740', 'spread': '8.929', 'groupId': 'OG000'}, {'value': '1.957', 'spread': '8.691', 'groupId': 'OG001'}, {'value': '6.943', 'spread': '9.347', 'groupId': 'OG002'}, {'value': '2.923', 'spread': '8.185', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the PH score from baseline, Week 8', 'categories': [{'measurements': [{'value': '4.763', 'spread': '9.311', 'groupId': 'OG000'}, {'value': '3.647', 'spread': '8.886', 'groupId': 'OG001'}, {'value': '7.457', 'spread': '9.115', 'groupId': 'OG002'}, {'value': '0.992', 'spread': '10.703', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the PH score from baseline, Week 12', 'categories': [{'measurements': [{'value': '5.117', 'spread': '8.731', 'groupId': 'OG000'}, {'value': '1.820', 'spread': '10.255', 'groupId': 'OG001'}, {'value': '7.804', 'spread': '8.574', 'groupId': 'OG002'}, {'value': '3.465', 'spread': '9.437', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the MH score from baseline, Week 4', 'categories': [{'measurements': [{'value': '6.633', 'spread': '7.020', 'groupId': 'OG000'}, {'value': '7.387', 'spread': '9.915', 'groupId': 'OG001'}, {'value': '4.196', 'spread': '11.329', 'groupId': 'OG002'}, {'value': '3.327', 'spread': '12.181', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the MH score from baseline, Week 8', 'categories': [{'measurements': [{'value': '8.773', 'spread': '9.176', 'groupId': 'OG000'}, {'value': '8.443', 'spread': '10.287', 'groupId': 'OG001'}, {'value': '6.364', 'spread': '9.946', 'groupId': 'OG002'}, {'value': '2.792', 'spread': '9.677', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the MH score from baseline, Week 12', 'categories': [{'measurements': [{'value': '10.437', 'spread': '8.939', 'groupId': 'OG000'}, {'value': '8.693', 'spread': '10.551', 'groupId': 'OG001'}, {'value': '5.686', 'spread': '9.925', 'groupId': 'OG002'}, {'value': '3.004', 'spread': '11.361', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being with 2 components (physical health score \\[PH\\] and mental component score \\[MH\\]). Both scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Changes of the DLQI score, Week 4', 'categories': [{'measurements': [{'value': '-9.833', 'spread': '7.292', 'groupId': 'OG000'}, {'value': '-9.000', 'spread': '6.988', 'groupId': 'OG001'}, {'value': '-8.143', 'spread': '5.662', 'groupId': 'OG002'}, {'value': '-4.308', 'spread': '7.121', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the DLQI score, Week 8', 'categories': [{'measurements': [{'value': '-11.967', 'spread': '7.462', 'groupId': 'OG000'}, {'value': '-11.133', 'spread': '7.380', 'groupId': 'OG001'}, {'value': '-10.679', 'spread': '5.157', 'groupId': 'OG002'}, {'value': '-4.846', 'spread': '7.619', 'groupId': 'OG003'}]}]}, {'title': 'Changes of the DLQI score, Week 12', 'categories': [{'measurements': [{'value': '-13.700', 'spread': '7.901', 'groupId': 'OG000'}, {'value': '-12.333', 'spread': '7.369', 'groupId': 'OG001'}, {'value': '-10.107', 'spread': '7.809', 'groupId': 'OG002'}, {'value': '-5.654', 'spread': '7.402', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The Dermatology Life Quality Index (DLQI) is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was assessed using a 3-point scale, where score 3 means "very much", score 2 means "a lot", score 1 - "a little", and score 0 - "not at all". If more than two questions were left unanswered, the questionnaire was considered invalid. A total score was calculated by summing the score of all items (total maximum score is 30; total minimum score is 0). The higher score representing greater health-related quality of life impairment.\n\nThe mean score change was estimated as the difference between the DLQI at baseline and at the assessed visit (the baseline score was subtracted from the visit score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was planned to include all patients who received at least one dose of BCD-085/placebo and who attended at least one post-dose visit. The efficacy population comprised of 114 patients.'}, {'type': 'SECONDARY', 'title': 'Frequency of AE/SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Any AEs/SAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Therapy-related AEs/SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'AEs, grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Therapy-related AEs, grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 weeks', 'description': 'Number of participants with AEs and SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).'}, {'type': 'SECONDARY', 'title': 'Frequency of Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 weeks', 'description': 'Number of participants with local reactions was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).'}, {'type': 'SECONDARY', 'title': 'Frequency of AE/SAE Grade 4 CTCAE 4.03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'title': 'Any AEs, grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 weeks', 'description': 'Number of participants with AEs/SAEs grade 4 CTCAE 4.03 was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).'}, {'type': 'SECONDARY', 'title': 'Frequency of Withdrawal Due to AE/SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-085, 40 mg', 'description': 'Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG001', 'title': 'BCD-085, 80 mg', 'description': 'Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG002', 'title': 'BCD-085, 120 mg', 'description': 'Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 weeks', 'description': 'Number of participants who withdrew due to AEs/SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis included all patients who received at least one dose of BCD-085 (31 in Arm 1, 30 in Arm 2, and 28 in each of arms 3 and 4, with the total number n=117).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BCD-085, 40 mg', 'description': 'Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'FG001', 'title': 'BCD-085, 80 mg', 'description': 'Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'FG002', 'title': 'BCD-085, 120 mg', 'description': 'Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BCD-085, 40 mg', 'description': 'Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'BG001', 'title': 'BCD-085, 80 mg', 'description': 'Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'BG002', 'title': 'BCD-085, 120 mg', 'description': 'Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nBCD-085'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.\n\nPlacebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '41.50', 'groupId': 'BG000', 'lowerLimit': '32.00', 'upperLimit': '50.00'}, {'value': '35.00', 'groupId': 'BG001', 'lowerLimit': '29.00', 'upperLimit': '45.00'}, {'value': '45.00', 'groupId': 'BG002', 'lowerLimit': '35.00', 'upperLimit': '54.00'}, {'value': '41.50', 'groupId': 'BG003', 'lowerLimit': '32.00', 'upperLimit': '48.00'}, {'value': '40.50', 'groupId': 'BG004', 'lowerLimit': '32.00', 'upperLimit': '50.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '82.00', 'groupId': 'BG000', 'lowerLimit': '70.00', 'upperLimit': '90.00'}, {'value': '80.50', 'groupId': 'BG001', 'lowerLimit': '65.00', 'upperLimit': '96.00'}, {'value': '87.25', 'groupId': 'BG002', 'lowerLimit': '76.00', 'upperLimit': '100.00'}, {'value': '77.55', 'groupId': 'BG003', 'lowerLimit': '64', 'upperLimit': '85'}, {'value': '82.00', 'groupId': 'BG004', 'lowerLimit': '70.00', 'upperLimit': '93.50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '178.50', 'groupId': 'BG000', 'lowerLimit': '170.00', 'upperLimit': '182.00'}, {'value': '173.00', 'groupId': 'BG001', 'lowerLimit': '166.00', 'upperLimit': '178.00'}, {'value': '177.00', 'groupId': 'BG002', 'lowerLimit': '169.40', 'upperLimit': '182.00'}, {'value': '175.00', 'groupId': 'BG003', 'lowerLimit': '164.00', 'upperLimit': '182.00'}, {'value': '176.00', 'groupId': 'BG004', 'lowerLimit': '168.00', 'upperLimit': '182.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '25.81', 'groupId': 'BG000', 'lowerLimit': '23.70', 'upperLimit': '29.09'}, {'value': '26.85', 'groupId': 'BG001', 'lowerLimit': '23.62', 'upperLimit': '29.59'}, {'value': '29.72', 'groupId': 'BG002', 'lowerLimit': '24.15', 'upperLimit': '31.94'}, {'value': '24.95', 'groupId': 'BG003', 'lowerLimit': '22.95', 'upperLimit': '30.12'}, {'value': '26.23', 'groupId': 'BG004', 'lowerLimit': '23.73', 'upperLimit': '30.60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Women With Child Bearing Potential', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Provided information only of the women enrolled in the study (35 subjects).'}], 'populationDescription': 'Provided information only of the patients included in the efficacy assessment (114 subjects).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-03', 'size': 426709, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-16T10:53', 'hasProtocol': False}, {'date': '2016-07-12', 'size': 8630177, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-17T07:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2016-04-01', 'resultsFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-26', 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With PASI 75 Response After 12 Weeks of Therapy', 'timeFrame': '12 weeks', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy', 'timeFrame': 'Week 4, Week 8', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement from baseline.'}, {'measure': 'Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.'}, {'measure': 'Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. 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: 0 (no disease) to 72 (maximal disease).\n\nRelative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)'}, {'measure': 'Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The area of skin affected by psoriasis (BSA) is estimated with the palm rule. The area of the human palm without fingers corresponds to about 1% of the body surface.\n\nRelative (percentage) from baseline is calculated as "100 x (baseline value - time point t value) / (baseline value)". If the value decreases from baseline it means improvement.'}, {'measure': 'Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085', 'timeFrame': 'Week 12', 'description': 'The NAPSI is used to assign a score to each nail involved, which can vary from 0 to 8. In this study, nail involvement will be assessed only for hands, so the total index of all nails can be from 0 to 80 (only hands). A negative change from baseline indicates improvement.\n\nRelative (percentage) change in NAPSI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)'}, {'measure': 'Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085', 'timeFrame': 'Week 1, Week 4, Week 8, Week 12', 'description': 'Mean change in severity of pruritus assessed by visual analog scale (from 0 (no itch) to 100 mm (unbearable itch)) after 1, 4, 8 and 12 weeks of treatment with BCD-085'}, {'measure': 'Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The sPGA scale is used to assess the psoriatic lesions in a certain patient from 0 (clear) to 5 (very severe). Within each area, the severity is estimated by three criteria (induration, desquamation, and erythema).'}, {'measure': 'Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being with 2 components (physical health score \\[PH\\] and mental component score \\[MH\\]). Both scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.'}, {'measure': 'Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'The Dermatology Life Quality Index (DLQI) is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was assessed using a 3-point scale, where score 3 means "very much", score 2 means "a lot", score 1 - "a little", and score 0 - "not at all". If more than two questions were left unanswered, the questionnaire was considered invalid. A total score was calculated by summing the score of all items (total maximum score is 30; total minimum score is 0). The higher score representing greater health-related quality of life impairment.\n\nThe mean score change was estimated as the difference between the DLQI at baseline and at the assessed visit (the baseline score was subtracted from the visit score).'}, {'measure': 'Frequency of AE/SAE', 'timeFrame': '14 weeks', 'description': 'Number of participants with AEs and SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.'}, {'measure': 'Frequency of Local Reactions', 'timeFrame': '14 weeks', 'description': 'Number of participants with local reactions was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.'}, {'measure': 'Frequency of AE/SAE Grade 4 CTCAE 4.03', 'timeFrame': '14 weeks', 'description': 'Number of participants with AEs/SAEs grade 4 CTCAE 4.03 was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.'}, {'measure': 'Frequency of Withdrawal Due to AE/SAE', 'timeFrame': '14 weeks', 'description': 'Number of participants who withdrew due to AEs/SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interleukin 17', 'monoclonal antibody', 'psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age between 18 and 65 years\n* Diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study.\n* Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment.\n* BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.\n* If patient have had biologic therapy for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.\n* Female patients have negative urine pregnancy test.\n* Patient has no history of tuberculosis.\n* Patients have negative results of Diaskintest.\n* Patient has no history of alcohol or drug abuse.\n* Patients are able to perform all procedures planed by protocol.\n* Patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug.\n\nExclusion Criteria:\n\n* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.\n* Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.\n* Prior use of two or more biologics to tumor necrosis factor alfa.\n* Prior use of two or more biologics to other targets.\n* Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.\n* Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.\n* Prior use of disease-modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, if their dose was not stable for up to 4 weeks before signing informed consent and during screening Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.\n* Prior use of phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent.'}, 'identificationModule': {'nctId': 'NCT02762994', 'briefTitle': 'International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'International Multi-center Comparative Randomized Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'BCD-085-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-085, 40 mg', 'description': 'Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.', 'interventionNames': ['Drug: BCD-085']}, {'type': 'EXPERIMENTAL', 'label': 'BCD-085, 80 mg', 'description': 'Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.', 'interventionNames': ['Drug: BCD-085']}, {'type': 'EXPERIMENTAL', 'label': 'BCD-085, 120 mg', 'description': 'Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.', 'interventionNames': ['Drug: BCD-085']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'BCD-085', 'type': 'DRUG', 'otherNames': ['monoclonal antibody to interleukin 17'], 'armGroupLabels': ['BCD-085, 120 mg', 'BCD-085, 40 mg', 'BCD-085, 80 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '198515', 'city': 'Saint Petersburg', 'state': 'Strelna', 'country': 'Russia', 'facility': 'BIOCAD', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Roman Ivanov, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'JCS BIOCAD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}