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A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

NCT04883619 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-27

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

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
2026-01-15
Primary Completion
2028-02-28
Completion
2028-02-28
FDA Drug
Yes

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Entities

Diseases

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 NCT04883619 on ClinicalTrials.gov