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Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Study acronym: POETYK PSO-LTE
StatusCompleted
PhasePhase 3
Started2019-08-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
Study Status, IPDSharing, References v23
Trial completed
Primary completion dateestimated 2026-07-25→confirmed 2026-07-21
Completion dateestimated 2026-07-26→confirmed 2026-07-21
Study sitesdetails revised at 1 of 302 sites
2025-10-17
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v22
Enrollment target1452→1466
Study sites301→302
Study arms1→2
InterventionsBMS-986165 (Drug)→BMS-986165 (Drug), Placebo (Drug)
Eligibility criteria+512 characters
Inclusion Criteria: Completion of the protocol-required treatment period in an [...] plicable study of BMS-986165 in moderate-to-severe psoriasis. Women must not be pregnant, lactating, or breastfeeding. Vaccine Cohort: 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. Exclusion Criteria: Any disease or medical condition that the investigator feel [...] ymptoms of tuberculosis (TB) as judged by the investigator [...]
Secondary endpoints2 to 10 entries
Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs) Pneumococc [...]
Primary endpoints2 to 4 entries
Proportion of participants achieving a satisfactory humoral response: pneumococcus Proportion of participants achieving a satisfactory humoral response: tetanus titers
2023-09-26
Study Status, Contacts/Locations v21
Study sites301 entries, revised
BiomedicLocal Skincare-Reena Simone Progressive Medical Research Radiant ResearchInstitution - Dallas Box Hill Hospital Fremantle Dermatology Centre de Recherche Dermatologique du Quebec Metropolitain0206 Local Institution University Hospital - Kyoto Preferctural University of Medicine Klinika Ambroziak Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska GCM Medical Group0198 Local Institution Hospital Universitario- de Gran Canaria Doctor Negrin0030 Local Institution - 0245 Local Institution - 0247 Local Institution - 0258 Local Institution - 0237 Local Institution - 006 [...]
2023-04-25
Study Status, Contacts/Locations, References v20
Study sites301 entries, revised
TheLocal Kirklin Clinic of UAB Hospital LA Universal Research Center San Luis Dermatology and Laser Clinic Unison Clinical Trials Skin Care Research San Marcus Research Clinic Olympian Clinical ResearchInstitution - Tampa Office Marietta Dermatology & The Skin Cancer Center Advanced Medical Research The Indiana Clinical Trials Center Skin Sciences ALLCUTIS Research Psoriasis Treatment Center of Central New Jersey Mount Sinai West Wright State Research Institute Oregon Dermatology and Research Center Dermatology [...] 0278 Local Institution Terveystalo Tampere Nagoya City University Hospital Shinshu U [...] [...]
2022-07-01
Study Status, Contacts/Locations v19
Study sites301 entries, revised
SomersetLocal SkinInstitution Centre National- Hospital Organization Yokohama Medical Center Kochi Medical School Hospital Osaka City University Hospital Nasz Lekarz Przychodnie Medyczne Hospital Universitario Fundacion Alcorcon0025 Local Institution - 0075 Local Institution - 0076 Local Institution - 0073 Local Institution - 0125 Local Institution - 0223 Local Institution - 0297
Show 18 earlier versions
2022-05-11
Study Status, Contacts/Locations v18
Study sites301 entries, revised
MiamiLocal DadeInstitution Medical- Research0216 Local Institute BethInstitution Israel- Deaconess Medical Center0291
2022-04-25
Study Status, Contacts/Locations v17
Study sites301 entries, revised
UniversityLocal California at Irvine Dermatology Clinical Research Center Moore Clinical ResearchInstitution - South Tampa DermResearch Center of New York Oregon Medical Research Center Synexus Arlington Center for Dermatology Metroplex Clinical Research Center0017 Local Institution Klinische Forschung- Hamburg GmbH Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk Lukasz Porawski Wieslawa Porawska Reumedika s. c. z siedziba w Poznaniu0233 Local Institution - 0218 Local Institution Hospital Universitario- Reina Sofia Karolinska Universitetssjukhuset0167 Local Institution - 0037 Local [...]
2022-03-07
Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1470→confirmed 1452
Study sites323→301
Eligibility criteria-120 characters
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: Completion of the protocol-required trea [...]
2021-11-09
Study Status, Study Design, Contacts/Locations, References v15
Enrollment target1680→1470
Study sitesdetails revised at 14 of 323 sites
2021-09-21
Study Identification, Study Status, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v14
Primary completion date2024-01-05→2026-07-25
Completion date2024-01-05→2026-07-26
Start date2020-01-20→2019-08-12
Study sites314→323
Eligibility criteria+178 characters
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: Completion of the protocol-required trea [...] symptoms of tuberculosis (TB) as judged by the investigator. Other protocol-defined inclusion/exclusion criteria apply
Primary endpoints1 to 2 entries
Incidence of Adverse Events (AEAEs) Incidence andof Serious Adverse Events (SAESAEs)
Study title+17 characters
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis.
2020-10-15
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 314 sites
2020-10-12
Study Status, Contacts/Locations v12
Study sites314 entries, revised
LocalWestmead InstitutionHospital
2020-10-08
Study Status, Contacts/Locations v11
Study sitesdetails revised at 8 of 314 sites
2020-10-06
Study Status, Contacts/Locations v10
Study sites314 entries, revised
LocalUniversity Institutionof California San Diego Health Systems LocalStratica InstitutionMedical LocalKlinische InstitutionForschung Hamburg GmbH LocalHospital InstitutionUniversitario Virgen de la Victoria LocalMounts InstitutionBay Medical
2020-09-25
Study Status, Contacts/Locations v9
Study sites313→314
2020-09-09
Study Status, Contacts/Locations v8
Study sites311→313
2020-08-21
Study Status, Contacts/Locations v7
Study sites310→311
2020-08-17
Study Status, Contacts/Locations v6
Study sites310 entries, revised
LocalKyoto InstitutionUniversity Hospital LocalKarolinska InstitutionUniversitetssjukhuset
2020-08-10
Study Status, Contacts/Locations v5
Study sites310 entries, revised
LocalThe InstitutionKirklin Clinic of UAB Hospital LocalNorth InstitutionEastern Health Specialists LocalGCM InstitutionMedical Group LocalThe InstitutionDudley Group NHS Foundation Trust
2020-08-06
Study Status, Contacts/Locations v4
Primary completion date2022-08-31→2024-01-05
Completion date2022-09-01→2024-01-05
Start date2019-07-19→2020-01-20
Study sites109→310
2019-10-07
Study Status, Contacts/Locations v3
Study sites102→109
2019-09-23
Study Status, Contacts/Locations v2
Study sites46→102
2019-09-04
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-08-14→confirmed 2019-07-19
Study sites40→46
2019-07-25
Original filing
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.
Trial Details
NCT Number NCT04036435
Lead Sponsor Bristol-Myers Squibb
Conditions Psoriasis
Enrollment 1,466 participants
Start Date 2019-08-12
Primary Completion 2026-07-21 (estimated)
Study Completion 2026-07-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-10