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Активно (без набиране) Фаза 3 NCT05620407

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Фаза 3 – широко изпитване преди одобрение
Заболявания: Systemic Lupus Erythematosus

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
Кой може да участва
Inclusion Criteria * Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit. * Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE. * One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening. * Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash. * Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry. * At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation. * Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant. Exclusion Criteria * Diagnosis of drug-induced SLE rather than idiopathic SLE. * Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded. * Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria. * Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS. * History of congenital or acquired immunodeficiency. * Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria). * Taking more than 1 immunosuppressant at screening. * In Japan only: Participants with positive result of β - D-glucan assay. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 21
Argentina (1)
Local Institution - 0146
Ciudad de Buenos Aires , Buenos Aires
Австралия (1)
Local Institution - 0179
Liverpool , New South Wales
Бразилия (1)
Local Institution - 0160
Vitória , Espírito Santo
България (1)
Local Institution - 0163
Sofia , Sofia (stolitsa)
Chile (1)
Local Institution - 0139
La Serena , Coquimbo Region
Чехия (1)
Local Institution - 0174
Ostrava , Ostrava Město
Гърция (1)
Local Institution - 0123
Athens , Attikí (Region)
Унгария (1)
Local Institution - 0057
Pécs , Baranya
Индия (1)
Local Institution - 0234
Ahmedabad , Gujarat
Япония (1)
Local Institution - 0053
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0107
Torreón , Coahuila
Peru (1)
Local Institution - 0208
Lima
Полша (1)
Local Institution - 0017
Poznan , Greater Poland Voivodeship
Puerto Rico (1)
Local Institution - 0240
Caguas
Сингапур (1)
Local Institution - 0135
Singapore
Испания (1)
Local Institution - 0151
Mérida , Badajoz
Taiwan (1)
Local Institution - 0094
Kaohsiung Niao Sung Dist , Kaohsiung
Тайланд (1)
Local Institution - 0212
Bangkok , Bangkok
Турция (1)
Local Institution - 0184
Ankara
Великобритания (1)
Local Institution - 0223
London , England
САЩ (1)
Local Institution - 0063
La Jolla , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
12.01.2023
Крайна дата
13.11.2028
Регистрационен номер
NCT05620407
Източник
anzctr
Запитване за медицински туризъм

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