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

Inclusion Criteria:

• Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE accordingto the SLE International Collaborating Clinics (SLICC) Classification Criteria atthe screening visit

• Test positive, as determined by the central laboratory, for at least one of thefollowing lupus related autoantibodies at the time of screening: antinuclearantibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, oranti-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 involvementand/or rash

Exclusion Criteria:

• Active severe lupus nephritis (LN) as assessed by the investigator

• Active or unstable neuropsychiatric lupus manifestations defined by the HybridSLEDAI

• Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis isnot SLE

• Antiphospholipid Syndrome

Other protocol-defined inclusion/exclusion criteria apply