Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT04487860
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fabio.ikedo@ache.com.br', 'phone': '55 11 26086933', 'title': 'Dr. Fabio Ikedo', 'organization': 'Aché Laboratórios Farmacêuticos S.A'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '64 Week', 'description': 'The Safety Population will consist of all subjects who were randomized into the study and dispensed study drug. This population will be the primary population for the safety analysis.\n\nSubjects will be analyzed according to the actual treatment received', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Part I', 'description': 'Placebo - Part I', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AS012 Dose Regimen I- Part I', 'description': 'AS012 dose x- Part I', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AS012 Dose Regimen II - Part I', 'description': 'AS012 dose 2x- Part I', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AS012 Dose Regimen III - Part I', 'description': 'AS012 dose 4x- Part I', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AS012 Dose Regimen IV - Part I', 'description': 'AS012 dose 6x- Part I', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo to AS012 Dose Regimen II at Week 24 - Part II', 'description': 'Placebo to AS012 dose 2x at Week 24 - Part II', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo to AS012 Dose Regimen IV at Week 24 - Part II', 'description': 'Placebo to AS012 dose 6x at Week 24 - Part II', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'AS012 Dose - Regimen I - Part II', 'description': 'AS012 dose X- Part II', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'AS012 Dose Regimen II - Part II', 'description': 'AS012 dose 2 x - Part II', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'AS012 Dose Regimen III - Part II', 'description': 'AS012 dose 4 x - Part II', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'AS012 Dose Regimen IV - Part II', 'description': 'AS012 dose 6 x - Part II', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'AS012 - Part III', 'description': 'treatment free', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Vitiligo Area Scoring Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'OG002', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'OG003', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'OG004', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.472', 'spread': '1.0422', 'groupId': 'OG000'}, {'value': '-0.271', 'spread': '2.5139', 'groupId': 'OG001'}, {'value': '-0.706', 'spread': '1.7301', 'groupId': 'OG002'}, {'value': '-1.145', 'spread': '2.7721', 'groupId': 'OG003'}, {'value': '-0.110', 'spread': '2.6168', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7905', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7372', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2989', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3328', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'OG002', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'OG003', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'OG004', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.507', 'spread': '1.7427', 'groupId': 'OG000'}, {'value': '-0.671', 'spread': '2.2065', 'groupId': 'OG001'}, {'value': '-0.284', 'spread': '2.4793', 'groupId': 'OG002'}, {'value': '-0.454', 'spread': '2.1214', 'groupId': 'OG003'}, {'value': '-1.218', 'spread': '3.3963', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8989', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6768', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8209', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3106', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Vitiligo Impact Patient Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'OG002', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'OG003', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'OG004', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.72', 'spread': '12.575', 'groupId': 'OG000'}, {'value': '-3.48', 'spread': '13.603', 'groupId': 'OG001'}, {'value': '-4.24', 'spread': '18.984', 'groupId': 'OG002'}, {'value': '-2.50', 'spread': '11.506', 'groupId': 'OG003'}, {'value': '-2.06', 'spread': '15.082', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8593', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9594', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9041', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7147', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to AS012 Dose Regimen II at Week 24', 'description': 'Placebo to AS012 dose 2x at Week 24'}, {'id': 'OG001', 'title': 'Placebo to AS012 Dose Regimen IV at Week 24', 'description': 'Placebo to AS012 dose 6x at Week 24'}, {'id': 'OG002', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'OG003', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'OG004', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'OG005', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician\'s Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Dermatology Life Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to AS012 Dose Regimen II at Week 24', 'description': 'Placebo to AS012 dose 2x at Week 24'}, {'id': 'OG001', 'title': 'Placebo to AS012 Dose Regimen IV at Week 24', 'description': 'Placebo to AS012 dose 6x at Week 24'}, {'id': 'OG002', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'OG003', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'OG004', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'OG005', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '3.08', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '4.76', 'groupId': 'OG003'}, {'value': '-2.0', 'spread': '3.49', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '2.51', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Part I: Up to 24 weeks: Subjects were randomized to Placebo\n\nPart II: week 24 to week 52: No Subjects\n\nPart III: week 52 to week 64: No Subjects'}, {'id': 'FG001', 'title': 'Placebo to AS012 Dose Regimen II at Week 24', 'description': 'Part I: Up to 24 weeks: No subjects\n\nPart II: week 24 to week 52: Subjects initially randomized to placebo were rerandomized to AS012 dose 2x\n\nPart III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}, {'id': 'FG002', 'title': 'Placebo to AS012 Dose Regimen IV at Week 24', 'description': 'Part I: Up to 24 weeks: No subjects\n\nPart II: week 24 to week 52: Subjects initially randomized to placebo were rerandomized to AS012 dose 6x\n\nPart III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}, {'id': 'FG003', 'title': 'AS012 Dose Regimen I', 'description': 'Part I: Up to 24 weeks: Subjects were randomized to AS012 dose x\n\nPart II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52).\n\nPart III: week 52 to week 64: After week 52,the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}, {'id': 'FG004', 'title': 'AS012 Dose Regimen II', 'description': 'Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 2x\n\nPart II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52).\n\nPart III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}, {'id': 'FG005', 'title': 'AS012 Dose Regimen III', 'description': 'Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 4x\n\nPart II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52).\n\nPart III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}, {'id': 'FG006', 'title': 'AS012 Dose Regimen IV', 'description': 'Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 6x\n\nPart II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52).\n\nPart III: week 52 to week 64: After week 52 the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '71'}, {'groupId': 'FG005', 'numSubjects': '63'}, {'groupId': 'FG006', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '18'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '34'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '16'}]}]}, {'title': 'Part 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '34'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '367', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG001', 'title': 'Placebo to AS012 Dose Regimen II at Week 24', 'description': 'Placebo to AS012 dose 2x at Week 24'}, {'id': 'BG002', 'title': 'Placebo to AS012 Dose Regimen IV at Week 24', 'description': 'Placebo to AS012 dose 6x at Week 24'}, {'id': 'BG003', 'title': 'AS012 Dose Regimen I', 'description': 'AS012 dose x'}, {'id': 'BG004', 'title': 'AS012 Dose Regimen II', 'description': 'AS012 dose 2x'}, {'id': 'BG005', 'title': 'AS012 Dose Regimen III', 'description': 'AS012 dose 4x'}, {'id': 'BG006', 'title': 'AS012 Dose Regimen IV', 'description': 'AS012 dose 6x'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Placebo and AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '327', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '14.65', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '14.85', 'groupId': 'BG003'}, {'value': '45.2', 'spread': '12.87', 'groupId': 'BG004'}, {'value': '46.8', 'spread': '14.52', 'groupId': 'BG005'}, {'value': '41.8', 'spread': '15.18', 'groupId': 'BG006'}, {'value': '45.1', 'spread': '14.49', 'groupId': 'BG007'}]}]}, {'title': 'Placebo to AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '45.6', 'spread': '14.81', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '16.76', 'groupId': 'BG002'}, {'value': '44.5', 'spread': '15.66', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Placebo and AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '327', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '171', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '156', 'groupId': 'BG007'}]}]}, {'title': 'Placebo to AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Placebo and AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '327', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '85', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}, {'value': '242', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}, {'title': 'Placebo to AS012 Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-20', 'size': 7184464, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-09T07:38', 'hasProtocol': True}, {'date': '2022-07-27', 'size': 2598417, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-09T07:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2023-03-09', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2020-07-22', 'resultsFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2020-07-24', 'dispFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-18', 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Vitiligo Area Scoring Index Score', 'timeFrame': 'Week 24', 'description': 'Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures', 'timeFrame': 'Week 24', 'description': 'The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population.'}, {'measure': 'Mean Change in Vitiligo Impact Patient Scale', 'timeFrame': 'Week 24', 'description': 'Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition.'}, {'measure': "Physician's Global Assessment Scores", 'timeFrame': 'Week 52', 'description': 'Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician\'s Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52.'}, {'measure': 'Mean Change From Baseline in Dermatology Life Quality Index', 'timeFrame': 'Week 52', 'description': 'The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-segmental Vitiligo']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Male or female ≥ 18 years of age at time of screening\n3. Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo\n4. VASI of ≥ 4 at screening and baseline\n\nExclusion Criteria:\n\n1. Segmental vitiligo, focal, or mixed Vitiligo\n2. Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment\n3. History of alcohol or drug abuse in the previous 2 years\n4. Subjects who were submitted to melanocyte transfer\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04487860', 'briefTitle': 'Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ache Laboratorios Farmaceuticos S.A.'}, 'officialTitle': 'A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo', 'orgStudyIdInfo': {'id': 'AS012-20-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AS012 dose regimen I', 'description': 'Oral', 'interventionNames': ['Drug: AS012']}, {'type': 'EXPERIMENTAL', 'label': 'AS012 dose regimen II', 'description': 'Oral', 'interventionNames': ['Drug: AS012']}, {'type': 'EXPERIMENTAL', 'label': 'AS012 dose regimen III', 'description': 'Oral', 'interventionNames': ['Drug: AS012']}, {'type': 'EXPERIMENTAL', 'label': 'AS012 dose regimen IV', 'description': 'Oral', 'interventionNames': ['Drug: AS012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AS012', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['AS012 dose regimen I', 'AS012 dose regimen II', 'AS012 dose regimen III', 'AS012 dose regimen IV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Pharma Site 15', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72022', 'city': 'Bryant', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Sun Pharma Site 02', 'geoPoint': {'lat': 34.59593, 'lon': -92.48905}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Sun Pharma Site 09', 'geoPoint': {'lat': 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'India', 'facility': 'Sun Pharma Site 26', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '313202', 'city': 'Rājsamand', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Sun Pharma Site 17', 'geoPoint': {'lat': 25.07145, 'lon': 73.8798}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Sun Pharma Site 27', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '226005', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Sun Pharma Site 18', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Sun Pharma Site 22', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ache Laboratorios Farmaceuticos S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}