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

Phase 3

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: BMS-986165; Drug: Placebo

• Registration Number: NCT04036435
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2019-08-12
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-17
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-07-25
• Study Completion: 2026-07-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1466

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165	BMS-986165	-
Vaccine Cohort	BMS-986165	-
Vaccine Cohort	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 244 weeks
Incidence of Serious Adverse Events (SAEs)	Up to 244 weeks
Proportion of participants achieving a satisfactory humoral response: pneumococcus	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	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 Outcome Measures

Name	Time	Method
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	Vaccine cohort only
Incidence of treatment-emergent adverse events (TEAEs)	At Week 4 after vaccination	Vaccine cohort only
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	Vaccine cohort only
Pneumococcal OPA geometric mean fold rise (GMFRs)	At Week 4 after vaccination	Vaccine cohort only
Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)	At Week 4 after vaccination	Vaccine cohort only
Incidence of serious adverse events (SAEs)	At Week 4 after vaccination	Vaccine cohort only
Incidence of AEs leading to discontinuation	At Week 4 after vaccination	Vaccine cohort only
Incidence of vaccine-specific AEs	At Week 4 after vaccination	Vaccine cohort only

Trial Locations

Locations (272)

Local Institution - 0046; 🇺🇸 Fountain Valley, California, United States

Local Institution - 0246; 🇦🇺 Darlinghurst, New South Wales, Australia

Local Institution - 0241; 🇦🇺 Woolloongabba, Queensland, Australia

Local Institution - 0152; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0163; 🇨🇿 Olomouc, Czechia

Local Institution - 0165; 🇨🇿 Ostrava, Czechia

Local Institution - 0151; 🇭🇺 Pécs, Hungary

Local Institution - 0069; 🇯🇵 Fukuoka, Fukuoka, Japan

Local Institution - 0061; 🇯🇵 Itabashi-Ku, Tokyo, Japan

Local Institution - 0096; 🇯🇵 Kumamoto, Japan

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