Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 3:32 AM
Study NCT ID:
NCT04036435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1466}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 244 weeks'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 244 weeks'}, {'measure': 'Proportion of participants achieving a satisfactory humoral response: pneumococcus', 'timeFrame': 'At Week 4 post vaccination', 'description': 'Vaccine cohort only\n\nDefined as ≥ 2-fold increase in immunoglobulin (IgG) antibody titers or geometric mean fold rise (GMFRs) titers of ≥ 6'}, {'measure': 'Proportion of participants achieving a satisfactory humoral response: tetanus titers', 'timeFrame': 'At Week 4 post vaccination', 'description': 'Vaccine cohort only\n\nA serologic response is defined as:\n\n* Postvaccination titer levels ≥ 0.40 IU/mL if prevaccination IgG antibody titer level is ≤ 0.10 IU/mL OR\n* Postvaccination titer levels of at least a 4-fold increase if prevaccination titer level is \\> 0.10 IU/mL and ≤ 2.7 IU/mL OR\n* Postvaccination titer levels of at least a 2-fold increase if prevaccination titer level is \\> 2.7 IU/mL'}], 'secondaryOutcomes': [{'measure': 'static Physician Global Assessment (sPGA) 0/1 response', 'timeFrame': 'Up to 240 weeks'}, {'measure': 'Psoriasis Area and Severity Index (PASI) 75 response', 'timeFrame': 'Up to 240 weeks'}, {'measure': 'Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Pneumococcal OPA geometric mean fold rise (GMFRs)', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Incidence of AEs leading to discontinuation', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}, {'measure': 'Incidence of vaccine-specific AEs', 'timeFrame': 'At Week 4 after vaccination', 'description': 'Vaccine cohort only'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '40113724', 'type': 'DERIVED', 'citation': 'Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.'}, {'pmid': '40066907', 'type': 'DERIVED', 'citation': 'Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.'}, {'pmid': '39602111', 'type': 'DERIVED', 'citation': 'Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT04036435.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis.\n* Women must not be pregnant, lactating, or breastfeeding.\n* Vaccine Cohort:\n\n 1. Subject must have moderate-to-severe plaque psoriasis, be currently receiving deucravacitinib treatment in the main IM011075 LTE cohort in the United States, Canada, or Poland, and must have completed at least one year of deucravacitinib treatment.\n\nExclusion Criteria\n\n* Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.\n* To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.\n* Vaccine Cohort:\n\n 1. Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1.\n 2. Subject received the Boostrix vaccine (as single or part of a combination vaccine) ≤ 5 years before Day 1.\n* Other protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04036435', 'acronym': 'POETYK PSO-LTE', 'briefTitle': 'Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'IM011-075'}, 'secondaryIdInfos': [{'id': '2019-000612-29', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986165', 'interventionNames': ['Drug: BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Vaccine Cohort', 'interventionNames': ['Drug: BMS-986165', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'otherNames': ['Deucravacitinib'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986165', 'Vaccine Cohort']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Vaccine Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 0278', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance Dermatology and Mohs Center - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus - Orange Grove Family Practice', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Johnson Dermatology', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Clinical Trials Center, PLLC', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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