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Clinical Trials in the UK / NCT05946941
Active, not recruiting Phase 3

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

NCT05946941 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-09-11
Last updated
2026-04-01

Condition(s) studied

Sjögren's Syndrome

Investigational drug(s) / intervention(s)

DeucravacitinibPlacebo

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (199)

FacilityCityRegionStatus
Local Institution - 0228 Fullerton California
Local Institution - 0222 La Palma California
Local Institution - 0218 San Francisco California
Local Institution - 0203 Santa Monica California
Local Institution - 0067 Denver Colorado
Local Institution - 0049 Clearwater Florida
Local Institution - 0226 Cooper City Florida
Local Institution - 0223 Sarasota Florida
Local Institution - 0140 Augusta Georgia
Local Institution - 0229 Lawrenceville Georgia
Local Institution - 0174 Skokie Illinois
Local Institution - 0016 Kansas City Kansas
Local Institution - 0017 Baton Rouge Louisiana
Local Institution - 0125 Monroe Louisiana
Local Institution - 0187 Baltimore Maryland
Local Institution - 0173 Boston Massachusetts
Local Institution - 0131 Eagan Minnesota
Local Institution - 0138 Summit New Jersey
Local Institution - 0009 Albuquerque New Mexico
Local Institution - 0184 Mineola New York
Local Institution - 0224 Salisbury North Carolina
Local Institution - 0130 Duncansville Pennsylvania
Local Institution - 0022 Jackson Tennessee
Local Institution - 0144 Allen Texas
Local Institution - 0227 Katy Texas
Local Institution - 0175 Plano Texas
Local Institution - 0133 Seattle Washington
Local Institution - 0189 Spokane Washington
Local Institution - 0050 San Isidro Alabama
Local Institution - 0100 CABA Buenos Aires
Local Institution - 0003 Ciudad Autonoma de Buenos Aires Buenos Aires
Local Institution - 0019 Quilmes Buenos Aires
Local Institution - 0026 San Miguel de Tucumán Tucumán Province
Local Institution - 0137 CABA Argentina
Local Institution - 0109 City of Buenos Aires Argentina
Local Institution - 0061 Córdoba Argentina
Local Institution - 0120 Woodville South South Australia
Local Institution - 0117 Graz Austria
Local Institution - 0087 Vienna Austria
Local Institution - 0172 Ghent Belgium

+ 159 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05946941 on ClinicalTrials.gov ↗ ← All trials in the UK