NCT04882878

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Detailed description

SLE is a complex, immune-mediated inflammatory disorder of unknown etiology that can affect almost any organ system and follows a waxing and waning disease course. In SLE, the immune system attacks the body cells and tissues and the resulting inflammation and tissue damage can harm the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. Nipocalimab 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). Thus, nipocalimab, a FcRn antibody, has potential in treatment of SLE through lowering of pathogenic IgGs and immune complexes. The study will consist of a Screening Period (less than or equal to \[\<=\] 6 Weeks), double-blind Treatment Period (52 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 64 weeks.

Conditions

• Systemic Lupus Erythematosus

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 immunomodulators, antimalarial drugs and GCs will be administered orally.

Timeline

• Start date: 2021-08-20
• Primary completion: 2024-04-30
• Completion: 2024-12-26
• First posted: 2021-05-12
• Last updated: 2025-12-08

Locations

86 sites across 12 countries: United States, Argentina, Bulgaria, Colombia, Germany, Hungary, Japan, Poland, South Africa, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study