NCT04883619

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Detailed description

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
OTHER	Placebo	Placebo will be administered intravenously.
DRUG	Nipocalimab	Nipocalimab dose 1 and dose 2 will be administered intravenously.
DRUG	Standard-of-care treatment	Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2021-05-12
• Last updated: 2026-02-27

Regulatory

• FDA-regulated drug study