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

Phase 3Active Not RecruitingNCT04036435

Bristol-Myers Squibb1,466 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,466

Conditions

Psoriasis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (302)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Local Institution - 0278

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center - Phoenix

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Synexus - Orange Grove Family Practice

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Up to 244 weeks

Incidence of Serious Adverse Events (SAEs)

Time frame: Up to 244 weeks

Proportion of participants achieving a satisfactory humoral response: pneumococcus

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

Time frame: At Week 4 post vaccination

Proportion of participants achieving a satisfactory humoral response: tetanus titers

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

Time frame: At Week 4 post vaccination

Secondary Outcomes

static Physician Global Assessment (sPGA) 0/1 response

Time frame: Up to 240 weeks

Psoriasis Area and Severity Index (PASI) 75 response

Time frame: Up to 240 weeks

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

Vaccine cohort only