Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-21 @ 4:11 AM
Study NCT ID:
NCT06258668
Status:
RECRUITING
Last Update Posted:
2024-11-06
First Post:
2024-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 505}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-02-03', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with adverse drug reactions (ADRs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with serious adverse drug reactions (SADRs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with unexpected adverse events (AEs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with unexpected adverse drug reactions (ADRs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with unexpected serious adverse events (SAEs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}, {'measure': 'Number of participants with unexpected serious adverse drug reactions (SADRs)', 'timeFrame': 'Up to 24 weeks from treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1', 'timeFrame': 'At Week 16 and/or Week 24 post treatment initiation'}, {'measure': 'Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)', 'timeFrame': 'At Week 16 and/or Week 24 post treatment initiation'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate-to-severe Plaque Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult patients in Korea who have been diagnosed with moderate-to-severe plaque psoriasis and have been prescribed treatment with deucravacitinib according to the approved product label.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants ≥19 years of age\n* Diagnosis of moderate-to-severe plaque psoriasis\n* Candidate for phototherapy or systemic therapy\n* Will begin deucravacitinib according to approved product label\n\nExclusion Criteria:\n\n* Participants prescribed deucravacitinib for therapeutic indications not approved in Korea\n* Participants for whom deucravacitinib is contraindicated as clarified in Korean prescribing information by ministry of food and drug safety (MFDS)'}, 'identificationModule': {'nctId': 'NCT06258668', 'briefTitle': 'Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'IM011-1122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants diagnosed with moderate-to-severe plaque psoriasis', 'interventionNames': ['Drug: Deucravacitinib']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'description': 'As per product label', 'armGroupLabels': ['Participants diagnosed with moderate-to-severe plaque psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06234', 'city': 'Seoul', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06234', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'South Korea Generic Country, Site 0002', 'role': 'CONTACT', 'phone': '0000000000'}], 'facility': 'Novotech Laboratory Korea Co., Ltd.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}