Home › Trials › NCT05946941

Evaluating Deucravacitinib for Active Sjögren's Syndrome in Adults

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

PHASE3 · Bristol-Myers Squibb · NCT05946941

This study is testing two different doses of Deucravacitinib to see if it can help adults with active Sjögren's Syndrome feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment756 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionsdeucravacitinib
Locations229 sites (Fullerton, California and 228 other locations)
Trial IDNCT05946941 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of active Sjögren's Syndrome who meet specific inclusion criteria.

Not a fit: Patients with other autoimmune diseases or those with poorly controlled fibromyalgia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from active Sjögren's Syndrome.

How similar studies have performed: Other studies have shown promise with similar treatments for autoimmune conditions, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Fullerton, California and 228 other locations

+179 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Sjögren's Syndrome, Deucravacitinib, Sjogren's Syndrome, BMS-986165, POETYK, Sjogren Syndrome, Sjogren-Larson Syndrome, Gougerot-Sjogren

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.