Overview
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
Inclusion Criteria
- 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.
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.