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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Sjögren's Syndrome

In brief

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.

Key facts

Study ID

NCT05946941

Run by

Bristol-Myers Squibb

People needed

774

Starts

2023-09-11

Expected to finish

2028-11-16

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0125 — Monroe, Louisiana, United States
• Local Institution - 0187 — Baltimore, Maryland, United States
• Local Institution - 0173 — Boston, Massachusetts, United States
• Local Institution - 0131 — Eagan, Minnesota, United States
• Local Institution - 0138 — Summit, New Jersey, United States
• Local Institution - 0009 — Albuquerque, New Mexico, United States
• Local Institution - 0184 — Mineola, New York, United States
• Local Institution - 0224 — Salisbury, North Carolina, United States
• Local Institution - 0130 — Duncansville, Pennsylvania, United States
• Local Institution - 0022 — Jackson, Tennessee, United States
• Local Institution - 0144 — Allen, Texas, United States
• Local Institution - 0227 — Katy, Texas, United States
• Local Institution - 0175 — Plano, Texas, United States
• Local Institution - 0133 — Seattle, Washington, United States
• Local Institution - 0189 — Spokane, Washington, United States
• Local Institution - 0050 — San Isidro, Alabama, Argentina
• Local Institution - 0100 — CABA, Buenos Aires, Argentina
• Local Institution - 0228 — Fullerton, California, United States
• Local Institution - 0222 — La Palma, California, United States
• Local Institution - 0218 — San Francisco, California, United States
• Local Institution - 0203 — Santa Monica, California, United States
• Local Institution - 0067 — Denver, Colorado, United States
• Local Institution - 0049 — Clearwater, Florida, United States
• Local Institution - 0226 — Cooper City, Florida, United States
• Local Institution - 0017 — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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