A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome - IM011-1069
Updated: 3 November, 2023 | ClinicalTrials.gov
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. Note: Other protocol-defined inclusion/exclusion criteria apply.