A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Inclusion Criteria:

• Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equalto (>=) 6 months prior to the screening visit and according to Systemic LupusInternational Collaborating Clinics (SLICC)-2012 classification criteria: at least 4criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion

• Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG Bscores observed during screening

• Must have at least moderately active SLE, as defined as systemic lupus erythematosusdisease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must alsohave SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excludingheadache and laboratory abnormalities) present at Week 0 prior to randomization

• Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activityscore of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both

• At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening

• Must be receiving 1 or more of the following protocol-permitted, systemicstandard-of-care treatments prior to first administration of study intervention at astable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

Exclusion Criteria:

• Current or history of, severe, progressive, or uncontrolled renal disease, with theexception of active lupus nephritis (LN). Have severe active LN as determined bysponsor (or designee) adjudication. Control of renal disease must be documented withat least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) overthe 6 months prior to screening

• Has any unstable or progressive manifestation of SLE that is likely to warrantescalation in therapy beyond permitted background medications

• Confirmed or suspected inflammatory diseases that might confound the evaluations ofefficacy

• Has a severe infection including opportunistic infections requiring parenteralanti-infectives, and/or hospitalization within 8 weeks prior to screening

• Has received a single B-cell targeting agent within 3 months prior to firstadministration of study intervention