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  • NCT05946941

Recruiting

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome - IM011-1069

Oppdatert: 9 desember, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • 90

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Deucravacitinib, Dose 1
Experimental: Deucravacitinib, Dose 2
Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Nøkkelkriterier for kvalifikasjon

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.

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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046