Active, Not Recruiting

Trial ID IM011-1069 | NCT05946941

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

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Summary

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.

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.

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.

Additional Information *

Study Arms

Experimental: Deucravacitinib, Dose 1

ASSIGNED INTERVENTION

Study Arms

Experimental: Deucravacitinib, Dose 2

ASSIGNED INTERVENTION

Study Arms

Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2

ASSIGNED INTERVENTION