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

NCT07438496 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2028-12-06
Completion
2031-11-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • China
  • Israel
  • Japan
  • Malaysia
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438496 on ClinicalTrials.gov