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Активно (без набиране) Фаза 3 NCT05946941

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Фаза 3 – широко изпитване преди одобрение
Заболявания: Sjögren's Syndrome

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Кой може да участва
Inclusion Criteria * Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening. * Have moderate to severe SjS ESSDAI ≥ 5. * Short duration of disease (≤ 10 years) before screening. * A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute). * Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening. Exclusion Criteria * Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis). * Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered. * Medical condition associated with sicca syndrome. * Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 30
Argentina (1)
Local Institution - 0050
San Isidro , Alabama
Австралия (1)
Local Institution - 0120
Woodville South , South Australia
Белгия (1)
Local Institution - 0172
Ghent
Бразилия (1)
Local Institution - 0170
Vitória , Espírito Santo
България (1)
Local Institution - 0008
Plovdiv
Канада (1)
Local Institution - 0134
Vancouver , British Columbia
Chile (1)
Local Institution - 0136
Santiago , Providencia
Китай (1)
Local Institution - 0153
Beijing , Beijing Municipality
Colombia (1)
Local Institution - 0168
Barranquilla , Atlántico
Финландия (1)
Local Institution - 0199
Helsinki
Франция (1)
Local Institution - 0005
Amiens
Германия (1)
Local Institution - 0079
Munich , Bavaria
Гърция (1)
Local Institution - 0077
Athens
Унгария (1)
Local Institution - 0083
Debrecen
Израел (1)
Local Institution - 0145
Ramat Gan , IA
Италия (1)
Local Institution - 0065
Brescia
Япония (1)
Local Institution - 0146
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0020
León , Guanajuato
Нидерландия (1)
Local Institution - 0001
Groningen
Peru (1)
Local Institution - 0047
Jesus Maria , Lima region
Полша (1)
Local Institution - 0084
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Local Institution - 0143
San Juan
Румъния (1)
Local Institution - 0220
Cluj-Napoca , Cluj
Южна Корея (1)
Local Institution - 0110
Seongdong-gu , Seoul
Испания (1)
Local Institution - 0038
Mérida , Badajoz
Швеция (1)
Local Institution - 0166
Gothenburg
Taiwan (1)
Local Institution - 0116
Kaohsiung City
Турция (1)
Local Institution - 0035
Yenimahalle , Ankara
Великобритания (1)
Local Institution - 0176
Southampton , Hampshire
САЩ (1)
Local Institution - 0228
Fullerton , California
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
11.09.2023
Крайна дата
16.11.2028
Регистрационен номер
NCT05946941
Източник
anzctr
Запитване за медицински туризъм

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