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Lupus Erythematosus, SystemicImmune and autoimmuneDrugPhase 3

What this study is

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).

What's being tested

  • Nipocalimab

    Intervention · DRUG

    Nipocalimab will be administered.

  • Placebo

    Intervention · DRUG

    Placebo will be administered.

  • Standard of care treatment

    Intervention · DRUG

    Protocol-defined topical and systemic standard of care background treatments.

Study details

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Sponsor
Janssen Research & Development, LLC
Conditions
Lupus Erythematosus, Systemic
Enrolling
600 people
Starts
2026-03-05
Est. completion
2031-11-07
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗