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Completed

NCT Number: NCT04036435

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Woden Dermatology, Phillip, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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:
  • Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1.
  • 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

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

Other names: Deucravacitinib

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 244 weeks

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 244 weeks

  3. Proportion of participants achieving a satisfactory humoral response: pneumococcus

    Time frame: 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

  4. Proportion of participants achieving a satisfactory humoral response: tetanus titers

    Time frame: 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 outcomes

  1. static Physician Global Assessment (sPGA) 0/1 response

    Time frame: Up to 240 weeks

  2. Psoriasis Area and Severity Index (PASI) 75 response

    Time frame: Up to 240 weeks

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

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

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

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

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

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

  6. Pneumococcal OPA geometric mean fold rise (GMFRs)

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

  8. Incidence of serious adverse events (SAEs)

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

  9. Incidence of AEs leading to discontinuation

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

  10. Incidence of vaccine-specific AEs

    Time frame: At Week 4 after vaccination

    Vaccine cohort only

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: POETYK PSO-LTE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2019
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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