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

Podrobnosti o hodnocení

Phase 2

Fáze
Pohlaví
18-70

Věková skupina
47

Umístění
Nábor

Možnosti léčby

Ramena studie

Přiřazená léčba

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

Klíčová kritéria způsobilosti

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

Tisk přehledného shrnutí

Podrobnosti o hodnocení

Možnosti léčby

Klíčová kritéria způsobilosti