Active Sjogren's Syndrome
Conditions
Interventions
Ducravacitinib is administered orally at a dosage of 3 mg or 6 mg twice daily.
Sponsors
Sreih Antoine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Satisfy the 2016 American College of Rheumatology/European League. Against Rheumatism criteria for the classification of SjS with disease duration (from time of diagnosis) of at least 16 weeks prior to screening. Have moderate to severe SjS ESSDAI >=5. Short duration of disease (=0.05 mililiters/minute (mL/minute). Positive anti-Sjogren's syndrome-associated antigen A (anti-Ro/SSA) at screening.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 Number of participants with decrease in ESSPRI >=1 or 15% from baseline at Week 52 Number of participants with decrease in ESSDAI >=3 points from baseline at Week 52 Number of participants with ESSDAI < 5 at Week 52 Change from baseline in ESSDAI at Week 24 Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 Change from baseline in physician global assessment (PhGA) at Week 52 Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 Change from baseline in oral dryness NRS at Week 52 Change from baseline in joint/ muscle pain NRS at Week 52 Number of participants with adverse events (AEs) Number of participants with serious AEs (SAEs) Number of participants with AEs leading to discontinuation of treatment and study discontinuation Number of participants with AEs of special interest (AESIs) Number of participants with clinical laboratory abnormalities Number of participants with electrocardiogram (ECG) abnormalities Number of participants with vital sign abnormalities | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey etc., United States
Contacts
Public ContactAntoine Sreih
Bristol-Myers Squibb
Outcome results
None listed