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

Purpose

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.

Condition

  • Sjögren's Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

  • 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Deucravacitinib, Dose 1
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
Experimental
Deucravacitinib, Dose 2
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
Placebo Comparator
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Ghaith Noaiseh, Site 0016
440-292-6948

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com