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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria


  1. 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.
  2. Have moderate to severe SjS ESSDAI ≥ 5.
  3. Short duration of disease (≤ 10 years) before screening.
  4. A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
  5. Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

EXCLUSION CRITERIA

Exclusion Criteria


  1. Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus [SLE], systemic sclerosis).
  2. 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.
  3. Medical condition associated with sicca syndrome.
  4. Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
  5. * Other protocol-defined Inclusion/Exclusion criteria apply.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study’s details


Contition
Sjögren's Syndrome
Age (in years)
18+
Phase
PHASE3
Participants needed
756
Est. Completion Date
Nov 16, 2028
Treatment type
INTERVENTIONAL

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05946941
Study number
IM0111069

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