Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-31 @ 8:07 AM
Study NCT ID:
NCT05701995
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months.', 'description': 'All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 32, 'seriousNumAtRisk': 119, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 12, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '42.5'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '16.2'}]}]}, {'title': 'Full Analysis Set Sub-population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '42.5'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '16.9'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '2.5', 'ciUpperLimit': '23.6', 'groupDescription': 'Full Analysis Set', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel (CMH)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '2.4', 'ciUpperLimit': '30.4', 'groupDescription': 'Full Analysis Set Sub-population', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel (CMH)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale:\n\n0=not at all\n\n1. a little\n2. a lot\n3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '80.3'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '40.0', 'upperLimit': '66.3'}]}]}, {'title': 'Full Analysis Set Sub-population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '81.0'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '67.5'}]}]}], 'analyses': [{'pValue': '0.0107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.2', 'ciUpperLimit': '4.4', 'groupDescription': 'Full Analysis Set', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel (CMH)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.2', 'ciUpperLimit': '4.7', 'groupDescription': 'Full Analysis Set Sub-population', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel (CMH)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment.\n\nThe DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3:\n\n0 = Not at all\n\n1. = A little\n2. = A lot\n3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Full Analysis Set Sub-population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-1.2', 'groupDescription': 'Full Analysis Set', 'statisticalMethod': 'Covariance model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-1.3', 'groupDescription': 'Full Analysis Set Sub-population', 'statisticalMethod': 'Covariance model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 16', 'description': "The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Randomized Participants Full Analysis Set Sub-Population: Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '45.4'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '19.6'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '2.0', 'ciUpperLimit': '17.4', 'groupDescription': 'Full Analysis Set Sub-population', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel (CMH)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'ALT or AST > 3 X ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 5 X ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin > 2 X ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 3 X ULN and Total Bilirubin > 2 X ULN on the same day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.\n\nALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'Hematology: Leukocytes (Grade 3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematology: Platelets (Grade 4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chemistry: Potassium (Grade 3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'title': 'Heart Rate (Beats/Min): Value > 100 And Change From Baseline > 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate (Beats/Min): Value < 55 And Change From Baseline < -15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate (Beats/Min): Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure (Mmhg): Value > 140 And Change From Baseline > 20', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure (Mmhg): Value < 90 And Change From Baseline < -20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure (Mmhg): Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure (Mmhg): Value > 90 And Change From Baseline > 10', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure (Mmhg): Value < 55 And Change From Baseline < -10', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure (Mmhg): Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min).\n\nClinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS-986165 6mg QD', 'description': 'Participants received deucravacitinib at a dose of 6 mg daily (QD)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo daily (QD)'}], 'periods': [{'title': 'Pre-Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Full Analysis Set/Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Full Analysis Set Sub-population', 'comment': 'All participants who were randomized to any treatment group with baseline static physician global assessment (s-PGA) \\>=3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Randomization Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': 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'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-25', 'size': 2706481, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T11:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2023-01-16', 'resultsFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-21', 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16', 'timeFrame': 'At Week 16', 'description': 'Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale:\n\n0=not at all\n\n1. a little\n2. a lot\n3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'timeFrame': 'At Week 16', 'description': "The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment.\n\nThe DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3:\n\n0 = Not at all\n\n1. = A little\n2. = A lot\n3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life."}, {'measure': 'Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16', 'timeFrame': 'Baseline and at Week 16', 'description': "The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching."}, {'measure': "Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16", 'timeFrame': 'At Week 16', 'description': "The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.\n\nALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal'}, {'measure': 'Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.'}, {'measure': 'Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16', 'timeFrame': 'From Week 0 through Week 16', 'description': 'Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min).\n\nClinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plaque psoriasis', 'deucravacitinib', 'BMS-986165', 'Health related quality of life (HrQoL)', 'QoL (quality of life)', 'SOTYKTU'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.\n* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.\n* ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1\n* Dermatology Life Quality Index (DLQI) score \\> 5 at the Screening Visit and Day 1\n* Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1\n\nExclusion Criteria:\n\nTarget Disease Exceptions:\n\n* Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1\n\nOther protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05701995', 'acronym': 'ARTISTYK', 'briefTitle': 'A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting', 'orgStudyIdInfo': {'id': 'IM011-237'}, 'secondaryIdInfos': [{'id': 'U1111-1276-5158', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo then Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib', 'Other: Placebo']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['BMS-986165', 'Sotyktu'], 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Deucravacitinib', 'Placebo then Deucravacitinib']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Placebo then Deucravacitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 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