A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05946941Tipo: INTERVENTIONALInicio: 11 de sept de 2023Fin estimado: 16 de nov de 2028

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Deucravacitinib

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0050

San Isidro, Alabama, Argentina

Local Institution - 0100

CABA, Buenos Aires, Argentina

Local Institution - 0003

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0019

Quilmes, Buenos Aires, Argentina

Local Institution - 0026

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0137

CABA, Argentina

Local Institution - 0109

City of Buenos Aires, Argentina

Local Institution - 0061

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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