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Recruiting

Trial ID IM011-1069  |   NCT05946941

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 97
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

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

            Exclusion Criteria

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

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      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
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