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)
Enter a location and click search to find clinical trials sorted by distance.
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