Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Psoriasis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 psor...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 12 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 26 2026

    Estimated Enrollment :

    1466 Patients enrolled

    Trial Details

    Trial ID

    NCT04036435

    Start Date

    August 12 2019

    End Date

    July 26 2026

    Last Update

    October 20 2025

    Active Locations (302)

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    Page 1 of 76 (302 locations)

    1

    Total Skin and Beauty Dermatology Center

    Birmingham, Alabama, United States, 35205

    2

    Local Institution - 0278

    Birmingham, Alabama, United States, 35233

    3

    Alliance Dermatology and Mohs Center - Phoenix

    Phoenix, Arizona, United States, 85032

    4

    Arizona Research Center

    Phoenix, Arizona, United States, 85053