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

Conditions

Psoriasis

Keywords

Psoriasis

Brief summary

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.

April W. Armstrong, Mark Lebwohl, Richard B. Warren, Akimichi Morita, C. Paul et al. (16 authors)

American Journal of Clinical Dermatology2026-08-06

10.1007/s40257-026-01055-w

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Plaque Psoriasis: In‐Depth Analysis of Efficacy and Safety in the Phase 3 <scp>POETYK PSO</scp>‐4 Trial

Yukari Okubo, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Katsuki Tsuritani et al. (11 authors)

The Journal of Dermatology2025-04-302 citations

10.1111/1346-8138.17744

Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials.

Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M.

2025-03-201 citations

10.1007/s13555-025-01362-w

Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials

April W. Armstrong, Richard B. Warren, Bruce Strober, Andrew Blauvelt, Yayoi Tada et al. (13 authors)

SKIN The Journal of Cutaneous Medicine2025-03-171 citations

10.25251/skin.10.supp.532

Deucravacitinib in Psoriasis Patients with a History of Malignancy: Follow-up after 4 Years of Deucravacitinib Treatment in the POETYK PSO Program

Mark Lebwohl, Neil J. Korman, Melinda Gooderham, Alice B. Gottlieb, Peter Foley et al. (15 authors)

SKIN The Journal of Cutaneous Medicine2025-03-17

10.25251/skin.10.supp.538

Deucravacitinib in Plaque Psoriasis: Immune Response to and Safety of Pneumococcus and Tetanus Toxoid Vaccines in the POETYK LTE Trial

Joanna Narbutt, Shahram Jacobs, Kim Papp, Alessandra Alió, Yi Luo et al. (9 authors)

SKIN The Journal of Cutaneous Medicine2025-03-17

10.25251/skin.10.supp.534

Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 <scp>POETYK PSO</scp>‐1, <scp>PSO</scp>‐4, and <scp>LTE</scp> trials

Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Yukari Okubo, Katsuyoshi Habiro et al. (10 authors)

The Journal of Dermatology2025-03-111 citations

10.1111/1346-8138.17685

P114 Deucravacitinib treatment did not affect immune response to SARS-Cov-2 vaccines and infection in patients with plaque psoriasis: results from the Phase 3 POETYK long-term extension trial

British Journal of Dermatology2024-12-01

10.1093/bjd/ljae360.144

Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years

April W. Armstrong, Mark Lebwohl, Richard B. Warren, Howard Sofen, Shinichi Imafuku et al. (20 authors)

JAMA Dermatology2024-11-2726 citations

10.1001/jamadermatol.2024.4688

Deucravacitinib in Plaque Psoriasis: Laboratory Parameters Through 4 Years of Treatment in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials

Neil J. Korman, Thierry Passeron, Yukari Okubo, Jerry Bagel, Richard B. Warren et al. (13 authors)

SKIN The Journal of Cutaneous Medicine2024-11-182 citations

10.25251/skin.8.supp.419

Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program

Mark Lebwohl, Richard B. Warren, Shinichi Imafuku, Jerry Bagel, April W. Armstrong et al. (12 authors)

SKIN The Journal of Cutaneous Medicine2024-11-18

10.25251/skin.8.supp.422

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA.

2024-07-305 citations

10.1007/s13555-024-01224-x

Deucravacitinib Long-Term Efficacy Through 4 years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program

Mark Lebwohl, Richard B. Warren, Shinichi Imafuku, Jerry Bagel, April W. Armstrong et al. (12 authors)

SKIN The Journal of Cutaneous Medicine2024-07-23

10.25251/skin.8.supp.408

P096 Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate-to-severe plaque psoriasis: safety profile in older (≥ 65 years) and younger (&lt; 65 years) patients in the phase III POETYK PSO-1, PSO-2 and long-term extension trials

Niamh Kearney, Andrew Pink, Kim Hoyt, Renata M Kisa, Subhashis Banerjee et al. (8 authors)

British Journal of Dermatology2024-06-28

10.1093/bjd/ljae090.123

Deucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials

April W. Armstrong, Mark Lebwohl, Richard B. Warren, Howard Sofen, Shinichi Imafuku et al. (18 authors)

SKIN The Journal of Cutaneous Medicine2024-03-181 citations

10.25251/skin.8.supp.366

Deucravacitinib Long-Term Efficacy in Week 16 Placebo Crossovers: 3-year Results from the POETYK PSO Program

Mark Lebwohl, Richard B. Warren, Shinichi Imafuku, Jerry Bagel, April W. Armstrong et al. (14 authors)

SKIN The Journal of Cutaneous Medicine2024-03-18

10.25251/skin.8.supp.365

Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials

April W. Armstrong, Mark Lebwohl, Richard B. Warren, Howard Sofen, Shinichi Imafuku et al. (18 authors)

SKIN The Journal of Cutaneous Medicine2023-11-131 citations

10.25251/skin.7.supp.240

Deucravacitinib Long-term Efficacy With Continuous Treatment in Plaque Psoriasis: 2-Year Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials

Diamant Thaçi, Mark Lebwohl, Richard B. Warren, Leon Kircik, Subhashis Banerjee et al. (10 authors)

SKIN The Journal of Cutaneous Medicine2023-11-13

10.25251/skin.7.supp.243

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis.

Armstrong AW, Park SH, Patel V, Hogan M, Wang WJ, Davidson D, Chirikov V.

2023-07-3114 citations

10.1007/s13555-023-00977-1

Deucravacitinib in plaque psoriasis: 2-year laboratory results from the phase 3 POETYK PSO program

Neil J. Korman, Thierry Passeron, Kenneth B. Gordon, Yukari Okubo, Jerry Bagel et al. (14 authors)

SKIN The Journal of Cutaneous Medicine2023-03-13

10.25251/skin.7.supp.119

Matching-adjusted indirect comparison (MAIC) of deucravacitinib versus adalimumab for the treatment of patients with moderate to severe plaque psoriasis over 2 years

April W. Armstrong, Sang Hee Park, Vardhaman Patel, Malcolm Hogan, Wei‐Jhih Wang et al. (7 authors)

SKIN The Journal of Cutaneous Medicine2023-03-13

10.25251/skin.7.supp.112

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial.

Thaçi D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB.

2022-01-1335 citations

10.1007/s13555-021-00649-y

Interventions

DRUGBMS-986165

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis. * Women must not be pregnant, lactating, or breastfeeding. * Vaccine Cohort: 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.

Exclusion criteria

* Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study. * To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator. * Vaccine Cohort: 1. Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1. 2. Subject received the Boostrix vaccine (as single or part of a combination vaccine) ≤ 5 years before Day 1. * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Events (AEs)	Up to 244 weeks	—
Incidence of Serious Adverse Events (SAEs)	Up to 244 weeks	—
Proportion of participants achieving a satisfactory humoral response: pneumococcus	At Week 4 post vaccination	Vaccine cohort only Defined as ≥ 2-fold increase in immunoglobulin (IgG) antibody titers or geometric mean fold rise (GMFRs) titers of ≥ 6
Proportion of participants achieving a satisfactory humoral response: tetanus titers	At Week 4 post vaccination	Vaccine cohort only A serologic response is defined as: * Postvaccination titer levels ≥ 0.40 IU/mL if prevaccination IgG antibody titer level is ≤ 0.10 IU/mL OR * 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 * Postvaccination titer levels of at least a 2-fold increase if prevaccination titer level is \> 2.7 IU/mL

Secondary

Measure	Time frame	Description
static Physician Global Assessment (sPGA) 0/1 response	Up to 240 weeks	—
Psoriasis Area and Severity Index (PASI) 75 response	Up to 240 weeks	—
Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL	At Week 4 after vaccination	Vaccine cohort only
Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC	At Week 4 after vaccination	Vaccine cohort only
Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)	At Week 4 after vaccination	Vaccine cohort only
Pneumococcal OPA geometric mean fold rise (GMFRs)	At Week 4 after vaccination	Vaccine cohort only
Incidence of treatment-emergent adverse events (TEAEs)	At Week 4 after vaccination	Vaccine cohort only
Incidence of serious adverse events (SAEs)	At Week 4 after vaccination	Vaccine cohort only
Incidence of AEs leading to discontinuation	At Week 4 after vaccination	Vaccine cohort only
Incidence of vaccine-specific AEs	At Week 4 after vaccination	Vaccine cohort only

Countries

Australia, Canada, China, Czechia, Finland, France, Germany, Hungary, Israel, Japan, New Zealand, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed