Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
BMS Recruiting Study icon

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
  • 90
    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
                      Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
                      Check Your Eligibility
                      Answer some questions about Your health to see if you may match to this trial
                      Match to a Trial
                      If you are a match, click on the study to see the list of study site locations
                      Select a Study Site Location
                      Select a study site location that is convenient for you
                      Register
                      Provide your contact details for the study site to connect with you.

                      Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you