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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05946941
Collaborator
(none)
756
Enrollment
26
Locations
3
Arms
63.3
Anticipated Duration (Months)
29.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date :
Aug 8, 2023
Anticipated Primary Completion Date :
Nov 18, 2026
Anticipated Study Completion Date :
Nov 16, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deucravacitinib, Dose 1

Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165

    		•
    Experimental: Deucravacitinib, Dose 2

    Drug: Deucravacitinib
    Specified dose on specified days
    Other Names:
  • BMS-986165

    		•
    Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2

    Drug: Deucravacitinib
    Specified dose on specified days
    Other Names:
  • BMS-986165

    • Other: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

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

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

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

    4. Number of participants with ESSDAI < 5 at Week 52 [Baseline, Week 52]

    5. Change from baseline in ESSDAI at Week 24 [Baseline, Week 24]

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

    7. Change from baseline in physician global assessment (PhGA) at Week 52 [Baseline, Week 52]

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

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

    10. Change from baseline in oral dryness NRS at Week 52 [Baseline, Week 52]

    11. Change from baseline in joint/ muscle pain NRS at Week 52 [Baseline, Week 52]

    12. Number of participants with adverse events (AEs) [Up to Week 160]

    13. Number of participants with serious AEs (SAEs) [Up to Week 160]

    14. Number of participants with AEs leading to discontinuation of treatment and study discontinuation [Up to Week 160]

    15. Number of participants with AEs of special interest (AESIs) [Up to Week 160]

    16. Number of participants with clinical laboratory abnormalities [Up to Week 160]

    17. Number of participants with electrocardiogram (ECG) abnormalities [Up to Week 156]

    18. Number of participants with vital sign abnormalities [Up to Week 160]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Note: Other protocol-defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence St. John's Health Center Santa Monica California United States 90404
    2 Denver Arthritis Clinic Denver Colorado United States 80230
    3 Arthritis and Diabetes Clinic Monroe Louisiana United States 71203
    4 Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center Summit New Jersey United States 07901
    5 New Mexico Clinical Research Osteoporosis Albuquerque New Mexico United States 87106
    6 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    7 West Tennessee Research Institute Jackson Tennessee United States 38305
    8 Local Institution - 0018 Sao Paulo Brazil 04266-010
    9 Local Institution - 0095 Guangzhou Guangdong China 510080
    10 Local Institution - 0212 Shenzhen Guangdong China 518020
    11 Local Institution - 0214 Zhengzhou Henan China 450052
    12 Local Institution - 0215 Nanjing Jiangsu China 210008
    13 Local Institution - 0213 Nanchang Jiangxi China 330006
    14 Local Institution - 0093 Wenzhou Zhejiang China 325015
    15 Local Institution - 0006 Glostrup Denmark 2600
    16 Local Institution - 0072 Orleans Centre France 45067
    17 Local Institution - 0074 Le Havre Cedex France 76083
    18 Local Institution - 0115 Budapest, IX Válassz Egy Opciót… Hungary 1097
    19 Local Institution - 0113 Budapest Hungary 1036
    20 Local Institution - 0082 Padua Italy 32128
    21 Local Institution - 0211 Nishinomiya-shi Hyogo-Ken Japan 6638501
    22 Local Institution - 0206 Kawasaki-shi Kanagawa Japan 2168511
    23 Local Institution - 0210 Bunkyo-ku Tokyo Japan 1138431
    24 Local Institution - 0190 Chuo-ku Tokyo Japan 1048560
    25 Local Institution - 0197 Shinjuku Tokyo Japan 1608582
    26 Local Institution - 0047 Jesus Maria Lima Peru 15076

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05946941
    Other Study ID Numbers:
    • IM011-1069
    • 2023-503327-26
    • U111-1289-6072
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Sjögren's syndrome
    BMS-986165
    POETYK
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Syndrome
    Deucravacitinib

    Study Results

    No Results Posted as of Jul 20, 2023