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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjögren’s Syndrome (POETYK SjS-1)

Sjogren's syndrome
All genders
person-wave 18+
Recruiting now
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Principal Investigator: Pedram Hamrah, MD

To assess the safety and efficacy of oral medication, deucravacitinib (DEUC) at 3 mg twice daily (BID) vs. 6 mg BID vs. the placebo in participants with active Sjögren’s syndrome (SjS).

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Karaghan Curran

Study details

Inclusion Criteria
  • 1. Individuals with positive anti-Sjögren’s syndrome-associated antigen A at screening.
  • 2. Stimulated whole salivary flow ≥ 0.05 mL/min or unstimulated whole saliva secretion
    ≥ 0.01 mL/min at screening
  • 3. Short duration of disease (≤ 10 years before screening)
Exclusion Criteria
  • 1. A systemic autoimmune disease other than SjS (eg, rheumatoid arthritis, SLE, systemic
  • 2. Tuberculosis in the past/currently active.
  • 3. Severe complications of SjS (vasculitis, lymphoma, active central nervous system or peripheral
    nervous system involvement, severe renal/pulmonary/muscular involvement).
Study Requirements

At eligibility visit, Chest X-ray, ECG, blood draw, and salivary flow assessment. 4 week screening/washout period prior, 52 weeks of treatment with visit to the clinic every 4 weeks

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