The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
LN is a heterogeneous autoimmune disease that includes a broad spectrum of clinical forms, ranging from those with lesions confined to the skin (cutaneous lupus erythematosus \[CLE\]) to others that involve one or more vital internal organs (systemic lupus erythematosus \[SLE\]). Renal involvement due to SLE is termed LN. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig) G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG into circulation, resulting in a decrease in circulating IgG antibody levels, including pathogenic IgG autoantibodies and alloantibodies. The study will consist of a screening period (less than or equal to \[\<=\] 8 Week), double-blind treatment period (52 Week), and a safety follow-up period (6 Week). Safety assessment will include adverse events (AEs), serious adverse events (SAEs), laboratory parameters (hematology and chemistry) and vital signs. The total duration of the main study is up to 66 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Placebo will be administered intravenously.
Nipocalimab dose 1 and dose 2 will be administered intravenously.
Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
Percentage of Participants Achieving Complete Renal Response (CRR)
Percentage of participants achieving complete renal response will be reported.
Time frame: Week 52
Percentage of Participants Achieving CRR
Percentage of participants achieving CRR will be reported.
Time frame: Week 24
Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52
Percentage of participants achieving at least 50% decrease in proteinuria will be reported.
Time frame: Baseline, Week 24 and Week 52
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent
Percentage of participants achieving a sustained reduction in steroid dose \<= 10 mg/day of prednisone or equivalent will be reported.
Time frame: Week 16 to Week 52
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Up to Week 66
Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
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Time frame: Up to Week 66
Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention
Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.
Time frame: Up to Week 52
Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs)
Percentage of participants with treatment-emergent AESIs will be reported.
Time frame: Up to Week 58
Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time
Percentage of participants with change from baseline in laboratory parameters (hematology and chemistry) will be reported.
Time frame: Up to week 58
Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time
Percentage of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time frame: Up to week 58
Serum Concentration of Nipocalimab Over Time
Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.
Time frame: Up to Week 58
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.
Time frame: Up to Week 58