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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Sjögren's Syndrome

Treatments: Other: Placebo; Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05946941

IM011-1069

2023-503327-26 (EudraCT Number)

U111-1289-6072 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 756 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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756 participants in 3 patient groups, including a placebo group

Deucravacitinib, Dose 1

Experimental group

Treatment:

Drug: Deucravacitinib

Deucravacitinib, Dose 2

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Placebo Comparator group

Treatment:

Drug: Deucravacitinib

Other: Placebo