Evaluating Deucravacitinib for Active Sjögren's Syndrome in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and efficacy of two different doses of Deucravacitinib in adults diagnosed with active Sjögren's Syndrome. Participants will be assessed based on specific criteria, including disease severity and duration, to determine the treatment's effectiveness compared to a placebo. The study will involve monitoring participants for improvements in symptoms and overall health related to Sjögren's Syndrome. The trial is designed to provide insights into how well Deucravacitinib can manage this autoimmune condition.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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.

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.

Where it's running

• Arthritis and Osteoporosis Medical Center
  La Palma, California, United States Recruiting
• UCSF Univ of California San Francisco
  San Francisco, California, United States Recruiting
• Providence St. John's Health Center
  Santa Monica, California, United States Recruiting
• Denver Arthritis Clinic
  Denver, Colorado, United States Recruiting
• Clinical Research of West Florida; Inc
  Clearwater, Florida, United States Recruiting
• Sarasota Arthritis Center
  Sarasota, Florida, United States Recruiting

+179 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.