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
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
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.
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:
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:
Other protocol-defined inclusion/exclusion criteria apply
Evansville, Indiana 47714, United States
Fort Gratiot, Michigan 48059, United States
New Brighton, Minnesota 55112, United States
St Louis, Missouri 63141, United States
North Charleston, South Carolina 29405, United States
North York, Ontario M2M 4J5, Canada
Itabashi-Ku, Tokyo 173-8606, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Minato-ku, Tokyo 105-8471, Japan
Shinagawa, Tokyo 141-8625, Japan
Shinjuku-ku, Tokyo 1600023, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Bialystok, 15-351, Poland
Elblag, 82-300, Poland
Krak, 30-510, Poland
Wroc?aw, 50-566, Poland
Cornwall, TR27 5DT, United Kingdom
Lancashire, FY2 0JH, United Kingdom
Leicestershire, LE10 2SE, United Kingdom