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  • NCT04895696

Recruiting

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

Opdateret: 20 november, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Udskriv denne side IM026-024
Hente vejledningen til forsøgsdeltagere

VÆLG SPROG

Forsøgsdetaljer

  • Phase 2

    Fase

  • Køn

  • 18-70

    Aldersinterval

  • 49

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
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

Primære egnethedskriterier

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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