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
Overview
- Phase
- Phase 3
- Intervention
- BMS-986165
- Conditions
- Psoriasis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 1466
- Locations
- 272
- Primary Endpoint
- Incidence of Adverse Events (AEs)
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BMS-986165
Intervention: BMS-986165
Vaccine Cohort
Intervention: BMS-986165
Vaccine Cohort
Intervention: Placebo
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
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
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
- 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)
- Incidence of treatment-emergent adverse events (TEAEs)(At Week 4 after vaccination)
- static Physician Global Assessment (sPGA) 0/1 response(Up to 240 weeks)
- Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC(At Week 4 after vaccination)
- Pneumococcal OPA geometric mean fold rise (GMFRs)(At Week 4 after vaccination)
- Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)(At Week 4 after vaccination)
- Incidence of serious adverse events (SAEs)(At Week 4 after vaccination)
- Incidence of AEs leading to discontinuation(At Week 4 after vaccination)
- Incidence of vaccine-specific AEs(At Week 4 after vaccination)