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A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

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ClinicalTrials.gov Identifier: NCT05946941
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sjögren's Syndrome Drug: Deucravacitinib Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : November 18, 2026
Estimated Study Completion Date : November 16, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Deucravacitinib, Dose 1 Drug: Deucravacitinib
Specified dose on specified days
Other Name: BMS-986165
Experimental: Deucravacitinib, Dose 2 Drug: Deucravacitinib
Specified dose on specified days
Other Name: BMS-986165
Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Drug: Deucravacitinib
Specified dose on specified days
Other Name: BMS-986165

Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 adverse events (AEs) [ Time Frame: Up to Week 160 ]
  13. Number of participants with serious AEs (SAEs) [ Time Frame: Up to Week 160 ]
  14. Number of participants with AEs leading to discontinuation of treatment and study discontinuation [ Time Frame: Up to Week 160 ]
  15. Number of participants with AEs of special interest (AESIs) [ Time Frame: Up to Week 160 ]
  16. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to Week 160 ]
  17. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to Week 156 ]
  18. Number of participants with vital sign abnormalities [ Time Frame: Up to Week 160 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946941


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05946941    
Other Study ID Numbers: IM011-1069
2023-503327-26 ( EudraCT Number )
U111-1289-6072 ( Registry Identifier: WHO )
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Deucravacitinib
Sjogren's Syndrome
BMS-986165
POETYK
Sjogren Syndrome
Sjogren-Larson Syndrome
 Gougerot-Sjogren
Gougerot Sjogren Syndrome
Sjogren
Sjogren's
Sjogren Disease
Sjogren's Disease
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
 Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Deucravacitinib
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action