A Phase 3 interventional study of BMS-986165 and Placebo in Psoriasis, sponsored by Bristol-Myers Squibb. Completed at 302 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 1,466 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Vaccine Cohort:
Exclusion Criteria
Vaccine Cohort:
Drug: BMS-986165
Drug: BMS-986165 · Drug: Placebo
Specified dose on specified days
Also known as: Deucravacitinib
Specified dose on specified days
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
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
Time frame: At Week 4 after vaccination
Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC
Vaccine cohort only
Time frame: At Week 4 after vaccination
Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)
Vaccine cohort only
Time frame: At Week 4 after vaccination
Pneumococcal OPA geometric mean fold rise (GMFRs)
Vaccine cohort only
Time frame: At Week 4 after vaccination
Incidence of treatment-emergent adverse events (TEAEs)
Vaccine cohort only
Time frame: At Week 4 after vaccination
Incidence of serious adverse events (SAEs)
Vaccine cohort only
Time frame: At Week 4 after vaccination
Incidence of AEs leading to discontinuation
Vaccine cohort only
Time frame: At Week 4 after vaccination
Incidence of vaccine-specific AEs
Vaccine cohort only
Time frame: At Week 4 after vaccination
Showing the first 100 of 302 sites across 20 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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