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Активно (без набиране) Фаза 3 NCT04036435

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriasis

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 20
Австралия (1)
Woden Dermatology
Phillip , Australian Capital Territory
Канада (1)
Beacon Dermatology
Calgary , Alberta
Китай (1)
Local Institution
Beijing , Beijing Municipality
Чехия (1)
Nemocnice Jihlava
Jihlava
Финландия (1)
Local Institution - 0279
Tampere
Франция (1)
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice
Германия (1)
Licca Clinical Research Institute
Augsburg
Унгария (1)
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest
Израел (1)
Local Institution - 0237
Haifa
Япония (1)
Local Institution - 0065
Nagoya , Aichi-ken
New Zealand (1)
Local Institution
Mount Cook
Полша (1)
Local Institution - 0138
Warsaw , Masovian Voivodeship
Puerto Rico (1)
Local Institution - 0289
San Juan
Russia (1)
Local Institution - 0172
Kazan'
Южна Корея (1)
Local Institution - 0306
Seongnam-si , Gyeonggi-do
Испания (1)
Local Institution - 0223
Alcorcón
Швеция (1)
Ladulaas Kliniska Studier
Borås
Taiwan (1)
Local Institution - 0079
Kaohsiung City
Великобритания (1)
MAC Clinical Research - Cannock
Cannock
САЩ (1)
Total Skin and Beauty Dermatology Center
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
12.08.2019
Крайна дата
26.07.2026
Регистрационен номер
NCT04036435
Източник
anzctr
Запитване за медицински туризъм

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