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A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Sjögren's Syndrome

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.

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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 Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Arthur Bookman, Site 0063

41660358005404
Sjogren's Clinic at the Mary Pack Arthritis Center
Sjogren's Clinic at the Mary Pack Arthritis Center
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Alice Mai, Site 0134

Diex Recherche Sherbrooke
Diex Recherche Sherbrooke
Sherbrooke, Quebec
Canada

Contact Study Team

Primary Contact

Hugues Allard-Chamard, Site 0004

18193462887
Centre De Recherche Musculo-Squelettique
Centre De Recherche Musculo-Squelettique
Trois Rivières, Quebec
Canada

Contact Study Team

Primary Contact

Frederic Morin, Site 0056

8193701301
Study Sponsored By
Bristol-Myers Squibb
Participants Required
More Information
Study ID: NCT05946941