This study is in progress, not accepting new patients

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

a study on Psoriasis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Psoriasis, deucravacitinib, BMS-986165

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join 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:
    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

  • University of California San Diego Health Systems
    San Diego 5391811 California 5332921 92122 United States
  • Local Institution - 0017
    Irvine 5359777 California 5332921 92697 United States
  • Clinical Science Institute
    Santa Monica 5393212 California 5332921 90404 United States
  • Local Institution - 0042
    Sherman Oaks 5395244 California 5332921 91403 United States
  • Dermatology Research Associates - Los Angeles
    Los Angeles 5368361 California 5332921 90045-3606 United States
  • Local Institution - 0046
    Fountain Valley 5350207 California 5332921 92708 United States
  • Local Institution - 0206
    Fresno 5350937 California 5332921 93720 United States
  • Therapeutics Clinical Research
    San Diego 5391811 California 5332921 92123 United States
  • University Dermatology Group
    San Diego 5391811 California 5332921 92123 United States
  • Local Institution - 0236
    Los Angeles 5368361 California 5332921 90057 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04036435
Phase
Phase 3 Psoriasis Research Study
Study Type
Interventional
Participants
About 1466 people participating
Last Updated