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  • NCT04895696

Active, Not Recruiting

A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) - IM026-024

Oppdatert: 15 april, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Skriv ut denne siden IM026-024
Last ned Veiledning for studiedeltakere

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Vis detaljer

  • Phase 2

    Fase

  • Kjønn

  • 18-70

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: BMS-986256: Dose 1
Drug: BMS-986256 (Oral)
Experimental: BMS-986256: Dose 2
Drug: BMS-986256 (Oral)
Experimental: BMS-986256: Dose 3
Drug: BMS-986256 (Oral)
Placebo Comparator: Placebo
Other: Placebo

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: - Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria ≥ 12 weeks before the screening visit - Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody. - Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash Exclusion Criteria: - Active severe lupus nephritis (LN) as assessed by the investigator - Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI - Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE - Antiphospholipid Syndrome 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