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NCT Number: NCT05946941

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Sjögren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0050, San Isidro, Alabama, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Other names: BMS-986165

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52

    Time frame: Baseline, Week 52

  2. Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52

    Time frame: Baseline, Week 52

  3. Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52

    Time frame: Baseline, Week 52

  4. Number of participants with ESSDAI < 5 at Week 52

    Time frame: Baseline, Week 52

  5. Change from baseline in ESSDAI at Week 24

    Time frame: Baseline, Week 24

  6. Change from baseline in stimulated whole salivary flow (SWSF) at Week 52

    Time frame: Baseline, Week 52

  7. Change from baseline in physician global assessment (PhGA) at Week 52

    Time frame: Baseline, Week 52

  8. Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52

    Time frame: Baseline, Week 52

  9. Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52

    Time frame: Baseline, Week 52

  10. Change from baseline in oral dryness NRS at Week 52

    Time frame: Baseline, Week 52

  11. Change from baseline in joint/ muscle pain NRS at Week 52

    Time frame: Baseline, Week 52

  12. Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal

    Time frame: Baseline, Week 52

  13. Number of participants with adverse events (AEs)

    Time frame: Up to Week 160

  14. Number of participants with serious AEs (SAEs)

    Time frame: Up to Week 160

  15. Number of participants with AEs leading to discontinuation of treatment and study discontinuation

    Time frame: Up to Week 160

  16. Number of participants with AEs of special interest (AESIs)

    Time frame: Up to Week 160

  17. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Week 160

  18. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Week 156

  19. Number of participants with vital sign abnormalities

    Time frame: Up to Week 160

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Acronym: POETYK SjS-1

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jul 14, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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