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

Trial Details

Phase 2

Phase
Gender(s)
18-70

Age Range
Active, Not Recruiting

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Experimental: Afimetoran: Dose 1

Drug: Afimetoran

Experimental: Afimetoran: Dose 2

Drug: Afimetoran

Experimental: Afimetoran: Dose 3

Drug: Afimetoran

Placebo Comparator: Placebo

Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at 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 - Active or unstable 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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Trial Details

Treatment Options

Key Eligibility Criteria