Sjögren's Syndrome
Conditions
Keywords
Deucravacitinib, Sjogren's Syndrome, BMS-986165, POETYK, Sjogren Syndrome, Sjogren-Larson Syndrome, Gougerot-Sjogren, Gougerot Sjogren Syndrome, Sjogren, Sjogren's, Sjogren Disease, Sjogren's Disease
Brief summary
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.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 | Baseline, Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 | Baseline, Week 52 |
| Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52 | Baseline, Week 52 |
| Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52 | Baseline, Week 52 |
| Number of participants with ESSDAI < 5 at Week 52 | Baseline, Week 52 |
| Change from baseline in ESSDAI at Week 24 | Baseline, Week 24 |
| Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 | Baseline, Week 52 |
| Change from baseline in physician global assessment (PhGA) at Week 52 | Baseline, Week 52 |
| Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 | Baseline, Week 52 |
| Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 | Baseline, Week 52 |
| Change from baseline in oral dryness NRS at Week 52 | Baseline, Week 52 |
| Change from baseline in joint/ muscle pain NRS at Week 52 | 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 | Baseline, Week 52 |
| Number of participants with adverse events (AEs) | Up to Week 160 |
| Number of participants with serious AEs (SAEs) | Up to Week 160 |
| Number of participants with AEs leading to discontinuation of treatment and study discontinuation | Up to Week 160 |
| Number of participants with AEs of special interest (AESIs) | Up to Week 160 |
| Number of participants with clinical laboratory abnormalities | Up to Week 160 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Week 156 |
| Number of participants with vital sign abnormalities | Up to Week 160 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed