Recruiting
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome - IM011-1069
Updated: 9 December, 2024 | ClinicalTrials.gov
Phase
Gender(s)
Age Range
Location(s)
Recruiting
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.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
466-SE-2100058
