A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjogrens Syndrome (POETYK SjS-1)
Inclusion criteria:
- Male or female ≥18 years.
- Classification of Sjögren’s Disease according to ACR/EULAR 2016 criteria
- Time since diagnosis of ≤10 years at screening
- Seropositive for anti-Ro/SSA antibodies at screening
- Stimulated whole salivary flow of ≥0.05 ml/min or unstimulated whole salivary flow of ≥0.01 ml/min at screening.
- Screening ESSDAI value ≥5 within the following 8 organ domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic, and biologic.
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