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

NCT05946941

Active Not RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Sjögren's Syndrome

Interventions: Deucravacitinib, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (199)
  • Fullerton, California, United States
  • La Palma, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Clearwater, Florida, United States
  • Cooper City, Florida, United States
  • Sarasota, Florida, United States
  • Augusta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Skokie, Illinois, United States
  • Kansas City, Kansas, United States
  • Baton Rouge, Louisiana, United States
  • Monroe, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Eagan, Minnesota, United States
  • Summit, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Mineola, New York, United States
  • Salisbury, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • Jackson, Tennessee, United States
  • Allen, Texas, United States
  • Katy, Texas, United States
  • Plano, Texas, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • San Isidro, Alabama, Argentina
  • CABA, Buenos Aires, Argentina
  • + 169 more on CT.gov