A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
- Registration Number
- NCT05946941
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 756
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Placebo - Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Deucravacitinib - Deucravacitinib, Dose 1 Deucravacitinib - Deucravacitinib, Dose 2 Deucravacitinib -
- Primary Outcome Measures
Name Time Method Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 Baseline, Week 52
- Secondary Outcome Measures
Name Time Method 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 ESSDAI < 5 at Week 52 Baseline, Week 52 Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 Baseline, Week 52 Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 Baseline, Week 52 Number of participants with AEs leading to discontinuation of treatment and study discontinuation Up to Week 160 Number of participants with clinical laboratory abnormalities Up to Week 160 Change from baseline in ESSDAI at Week 24 Baseline, Week 24 Change from baseline in physician global assessment (PhGA) 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 of special interest (AESIs) Up to Week 160 Number of participants with vital sign abnormalities Up to Week 160 Change from baseline in joint/ muscle pain NRS at Week 52 Baseline, Week 52 Change from baseline in oral dryness NRS at Week 52 Baseline, Week 52 Number of participants with electrocardiogram (ECG) abnormalities Up to Week 156 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 Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 Baseline, Week 52
Trial Locations
- Locations (229)
Local Institution - 0228
🇺🇸Fullerton, California, United States
Arthritis and Osteoporosis Medical Center
🇺🇸La Palma, California, United States
UCSF Univ of California San Francisco
🇺🇸San Francisco, California, United States
Providence St. John's Health Center
🇺🇸Santa Monica, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Clinical Research of West Florida; Inc
🇺🇸Clearwater, Florida, United States
GNP Research
🇺🇸Cooper City, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Local Institution - 0229
🇺🇸Lawrenceville, Georgia, United States
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