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Active (not recruiting) Phase 3 NCT04036435

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

Phase 3 – large-scale trial before approval
Conditions: Psoriasis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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: 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. 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: 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 20
Australia (1)
Woden Dermatology
Phillip , Australian Capital Territory
Canada (1)
Beacon Dermatology
Calgary , Alberta
China (1)
Local Institution
Beijing , Beijing Municipality
Czech Republic (1)
Nemocnice Jihlava
Jihlava
Finland (1)
Local Institution - 0279
Tampere
France (1)
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice
Germany (1)
Licca Clinical Research Institute
Augsburg
Hungary (1)
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest
Israel (1)
Local Institution - 0237
Haifa
Japan (1)
Local Institution - 0065
Nagoya , Aichi-ken
New Zealand (1)
Local Institution
Mount Cook
Poland (1)
Local Institution - 0138
Warsaw , Masovian Voivodeship
Puerto Rico (1)
Local Institution - 0289
San Juan
Russia (1)
Local Institution - 0172
Kazan'
South Korea (1)
Local Institution - 0306
Seongnam-si , Gyeonggi-do
Spain (1)
Local Institution - 0223
Alcorcón
Sweden (1)
Ladulaas Kliniska Studier
Borås
Taiwan (1)
Local Institution - 0079
Kaohsiung City
United Kingdom (1)
MAC Clinical Research - Cannock
Cannock
United States (1)
Total Skin and Beauty Dermatology Center
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.08.2019
Completion date
26.07.2026
Registry ID
NCT04036435
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.