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Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
NCT05946941Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2023
- Primary completion
- Nov 2026
- Countries
- 33
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules
- Drugs
- deucravacitinib
- Conditions
- Sjögren's syndrome
01
Overview
Phase 3, randomised, double-blind trial of deucravacitinib in Sjögren's syndrome (3 arms), sponsored by Bristol Myers Squibb. Primary endpoint: European League Against Rheumatism Sjögren's Syndrome Disease Activity Index at 52 weeks. Started Sep 2023; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Deucravacitinib, Dose 1
Participants receive Deucravacitinib Dose 1.
Deucravacitinib, Dose 2
Participants receive Deucravacitinib Dose 2.
Placebo -> Deucravacitinib
Participants receive Placebo up to Week 52, then switch to Deucravacitinib Dose 1 or Dose 2.
03
Who it enrols
Adults with active Sjögren's syndrome (ESSDAI >= 5) for 16 weeks to 10 years, positive for anti-Ro/SSA, with stimulated whole salivary flow >= 0.05 mL/min. Excludes other autoimmune diseases and prior TYK2 inhibitor exposure.
04
Endpoints
Primary
European League Against Rheumatism Sjögren's Syndrome Disease Activity Index
Secondary
European League Against Rheumatism Sjögren's Syndrome Patient Reported Index
Decrease in ESSPRI >= 1 or 15% from baseline
Decrease in ESSDAI >= 3 points from baseline
ESSDAI < 5
European League Against Rheumatism Sjögren's Syndrome Disease Activity Index
Stimulated whole salivary flow
Physician global assessment
Functional assessment of chronic illness therapy-fatigue
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