The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
774
Specified dose on specified days
Specified dose on specified days
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Time frame: Baseline, Week 52
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Time frame: Baseline, Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Time frame: Baseline, Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Time frame: Baseline, Week 52
Number of participants with ESSDAI < 5 at Week 52
Time frame: Baseline, Week 52
Change from baseline in ESSDAI at Week 24
Time frame: Baseline, Week 24
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Time frame: Baseline, Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Time frame: Baseline, Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Time frame: Baseline, Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Time frame: Baseline, Week 52
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Local Institution - 0228
Fullerton, California, United States
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La Palma, California, United States
Local Institution - 0218
San Francisco, California, United States
Local Institution - 0203
Santa Monica, California, United States
Local Institution - 0067
Denver, Colorado, United States
Local Institution - 0049
Clearwater, Florida, United States
Local Institution - 0226
Cooper City, Florida, United States
Local Institution - 0223
Sarasota, Florida, United States
Local Institution - 0140
Augusta, Georgia, United States
Local Institution - 0229
Lawrenceville, Georgia, United States
...and 189 more locations
Change from baseline in oral dryness NRS at Week 52
Time frame: Baseline, Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Time frame: Baseline, Week 52
Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal
Time frame: Baseline, Week 52
Number of participants with adverse events (AEs)
Time frame: Up to Week 160
Number of participants with serious AEs (SAEs)
Time frame: Up to Week 160
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Time frame: Up to Week 160
Number of participants with AEs of special interest (AESIs)
Time frame: Up to Week 160
Number of participants with clinical laboratory abnormalities
Time frame: Up to Week 160
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Week 156
Number of participants with vital sign abnormalities
Time frame: Up to Week 160