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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Sjögren's Syndrome

Intervention / Treatment
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* Drug: Deucravacitinib
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deucravacitinib, Dose 1<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|
| Experimental: Deucravacitinib, Dose 2<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|
| Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 |  | Baseline, Week 52 | 
| Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52 |  | Baseline, Week 52 | 
| Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52 |  | Baseline, Week 52 | 
| Number of participants with ESSDAI < 5 at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in ESSDAI at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in physician global assessment (PhGA) at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in oral dryness NRS at Week 52 |  | Baseline, Week 52 | 
| Change from baseline in joint/ muscle pain NRS at Week 52 |  | Baseline, Week 52 | 
| Number of participants with adverse events (AEs) |  | Up to Week 160 | 
| Number of participants with serious AEs (SAEs) |  | Up to Week 160 | 
| Number of participants with AEs leading to discontinuation of treatment and study discontinuation |  | Up to Week 160 | 
| Number of participants with AEs of special interest (AESIs) |  | Up to Week 160 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Week 160 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Week 156 | 
| Number of participants with vital sign abnormalities |  | Up to Week 160 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deucravacitinib, Sjögren's syndrome, BMS-986165, POETYK