NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• 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 how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Nipocalimab	Nipocalimab will be administered.
DRUG	Placebo	Placebo will be administered.
DRUG	Standard of care treatment	Protocol-defined topical and systemic standard of care background treatments.

Timeline

• Start date: 2026-03-05
• Primary completion: 2028-12-06
• Completion: 2031-11-07
• First posted: 2026-02-27
• Last updated: 2026-04-13

Locations

27 sites across 6 countries: United States, Brazil, Israel, Malaysia, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study