A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2)

STUDY OVERVIEW

This study sponsored by Bristol-Myers Squibb aims to assess the efficacy and safety of deucravacitinib versus placebo in individuals with active moderate to severe Systemic Lupus Erythematosus (SLE).

STUDY GOALS

The goal of this study is to determine the efficacy and safety of deucravacitinib compared to placebo in treating active moderate to severe Systemic Lupus Erythematosus (SLE) patients.

LOCATION

El Paso, Texas: Texas Arthritis Center

INCLUSION CRITERIA

  • Diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks before screening.

  • Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

  • Positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.

  • Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.

  • Stable use of at least one SLE background therapy (immunosuppressant and/or antimalarial) for ≥ 12 weeks before screening, with a stable dose for ≥ 8 weeks before screening, and to remain stable until randomization and throughout the study.

  • Oral corticosteroid (OCS; prednisone or equivalent) background therapy permitted but not required. For participants on OCS, the dose must be stable for ≥ 2 weeks before screening, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit.

exclusion criteria

  • Diagnosis of drug-induced SLE rather than idiopathic SLE.

  • Exclusion of other autoimmune diseases (e.g., multiple sclerosis, psoriasis, inflammatory bowel disease, etc.), except for specified conditions such as type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome.

  • Active or unstable lupus neuropsychiatric manifestations, including conditions defined by BILAG A criteria.

  • Active, severe Class III and IV lupus nephritis requiring or possibly requiring treatment with cytotoxic agents or high-dose CS.

  • History of congenital or acquired immunodeficiency.

  • Known active infection, or major episode of infection requiring hospitalization or parenteral antimicrobial agents within 30 days of randomization, or oral antimicrobial agents within 2 weeks of randomization.

  • Currently on any therapy for chronic infection.

  • Taking more than 1 immunosuppressant at screening.

  • In Japan only: Participants with positive results of β-D-glucan assay.

For more information, visit ClinicalTrials.gov.