A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Sjögren's SyndromeThe purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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/Exclusion criteria apply.
Study Location
University Health Network - Toronto Western Hospital
University Health Network - Toronto Western HospitalToronto, Ontario
Canada
Contact Study Team
Arthur Bookman, Site 0063
41660358005404Sjogren's Clinic at the Mary Pack Arthritis Center
Sjogren's Clinic at the Mary Pack Arthritis CenterVancouver, British Columbia
Canada
Contact Study Team
Alice Mai, Site 0134
Diex Recherche Sherbrooke
Diex Recherche SherbrookeSherbrooke, Quebec
Canada
Contact Study Team
Hugues Allard-Chamard, Site 0004
18193462887Centre De Recherche Musculo-Squelettique
Centre De Recherche Musculo-SquelettiqueTrois Rivières, Quebec
Canada
Contact Study Team
Frederic Morin, Site 0056
8193701301- Study Sponsored By
- Bristol-Myers Squibb
- Participants Required
- More Information
- Study ID:
NCT05946941