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Biomedica Research Group | Santiago, Chile

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

Bristol-Myers Squibb (BMS) logo

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

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

Trial contacts and locations

221

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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