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

Brief Title

Categories

Skin/Dermatology

Completion Date

2026-07-26

Completion Date Type

Estimated

Conditions

Psoriasis

Eligibility Criteria

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/exclusion criteria apply

Inclusion Criteria

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.

inclusion/

Gender

All

Gender Based

false

Keywords

Psoriasis

Healthy Volunteers

No

Last Update Post Date

Mon, 10/20/2025 - 12:00

Last Update Post Date Type

Estimated

Last Update Submit Date

Fri, 10/17/2025 - 12:00

Minimum Age

18 Years

NCT Id

NCT04036435

Org Class

Industry

Org Full Name

Bristol-Myers Squibb

Org Study Id

IM011-075

Overall Status

Active, not recruiting

Phases

Phase 3

Primary Completion Date

Sat, 07/25/2026 - 12:00

Primary Completion Date Type

Estimated

Official Title

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

Primary Outcomes

Outcome Measure

Incidence of Adverse Events (AEs)

Outcome Time Frame

Up to 244 weeks

Outcome Measure

Incidence of Serious Adverse Events (SAEs)

Outcome Time Frame

Up to 244 weeks

Outcome Description

Vaccine cohort only

Defined as ≥ 2-fold increase in immunoglobulin (IgG) antibody titers or geometric mean fold rise (GMFRs) titers of ≥ 6

Outcome Measure

Proportion of participants achieving a satisfactory humoral response: pneumococcus

Outcome Time Frame

At Week 4 post vaccination

Outcome Description

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

Outcome Measure

Proportion of participants achieving a satisfactory humoral response: tetanus titers

Outcome Time Frame

At Week 4 post vaccination

Secondary Ids

Secondary Id

2019-000612-29

Secondary Outcomes

Outcome Time Frame

Up to 240 weeks

Outcome Measure

static Physician Global Assessment (sPGA) 0/1 response

Outcome Time Frame

Up to 240 weeks

Outcome Measure

Psoriasis Area and Severity Index (PASI) 75 response

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Pneumococcal OPA geometric mean fold rise (GMFRs)

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs)

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Incidence of serious adverse events (SAEs)

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Incidence of AEs leading to discontinuation

Outcome Description

Vaccine cohort only

Outcome Time Frame

At Week 4 after vaccination

Outcome Measure

Incidence of vaccine-specific AEs