A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
756 patients around the world
Available in Puerto Rico, United States, Mexico, Chile, Peru, Argentina, Brazil
Bristol-Myers Squibb
21Research sites
756Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS with disease duration (from time of 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.
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.
Sites
CER Instituto Médico - Quilmes, Buenos Aires
Recruiting
Av. Vicente Lopez 1441, Quilmes, Buenos Aires
Instituto Médico de Alta Complejidad San Isidro IMACSI
Recruiting
Av. del Libertador 16958, San Isidro, Buenos Aires
Investigaciones Reumatológicas y Osteológicas IRO
Recruiting
Jose E Uriburu 1170 Primer Piso, CABA, Buenos Aires
Consultora Integral de Salud SRL - Centro Médico Privado
Recruiting
Viamonte 544, Barrio General Paz - Córdoba
Swiss Medical Center Barrio Parque - CABA
Recruiting
San Martín de Tours 2980, CABA, Buenos Aires
Instituto Médico Especializado (IME)
Recruiting
Hidalgo 568, CABA, Buenos Aires
Fundación Respirar
Recruiting
Av. Cabildo 1548, CABA, Buenos Aires
Hospital Privado de Córdoba
Recruiting
Naciones Unidas 346, Córdoba
Centro de Investigaciones Médicas Tucumán
Recruiting
Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
R. Moreira e Costa, 342 - Ipiranga, São Paulo - SP, 04266-010