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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT04036435

Run by

Bristol-Myers Squibb

People needed

1466

Starts

2019-08-12

Expected to finish

2026-07-26

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Johnson Dermatology — Fort Smith, Arkansas, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Northwest Arkansas Clinical Trials Center, PLLC — Rogers, Arkansas, United States
• Local Institution - 0046 — Fountain Valley, California, United States
• Local Institution - 0206 — Fresno, California, United States
• Local Institution - 0017 — Irvine, California, United States
• Interspond - Long Beach Clinical Trials — Long Beach, California, United States
• Dermatology Research Associates - Los Angeles — Los Angeles, California, United States
• Local Institution - 0236 — Los Angeles, California, United States
• University of California San Diego Health Systems — San Diego, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• University Dermatology Group — San Diego, California, United States
• Local Institution - 0094 — San Luis Obispo, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• NorthBay Clinical Research — Santa Rosa, California, United States
• Synexus - Santa Rosa — Santa Rosa, California, United States
• Local Institution - 0042 — Sherman Oaks, California, United States
• Care Access Research - Walnut Creek — Walnut Creek, California, United States
• New England Research Associates — Bridgeport, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Total Skin and Beauty Dermatology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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