A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
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 (≤ 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
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 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.
Study Details
Contition
Sjögren's Syndrome
Age
18+
Phase
PHASE3
Participants Needed
756
Est. Completion Date
Nov 16, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT05946941
Study Number
IM0111069
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