What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis include immunosuppressive therapies such as cyclophosphamide and mycophenolate mofetil, as well as biologics like rituximab. Side effects of these treatments can include increased risk of infections, gastrointestinal disturbances, bone marrow suppression, and potential liver toxicity. Rituximab, specifically, may cause infusion reactions, hypogammaglobulinemia, and rare but serious conditions like progressive multifocal leukoencephalopathy (PML).

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including immunosuppressive drugs like mycophenolate mofetil and cyclophosphamide, as well as biologics such as belimumab, which targets B-lymphocyte stimulator (BLyS). While specific FDA approvals for drugs that inhibit the neonatal Fc receptor, like nipocalimab, are not detailed, the general approach of reducing pathogenic antibodies is a common therapeutic strategy in managing Lupus Nephritis.

What other types of research exist?

Promising novel alternatives to Nipocalimab for Lupus Nephritis patients include Rituximab, which targets CD20 on B cells and has shown efficacy in various autoimmune conditions, and Mycophenolate Mofetil (MMF), which is used as an immunosuppressive agent in patients who cannot tolerate glucocorticoids. Both treatments have been evaluated for their effectiveness in related renal and autoimmune conditions.

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Monoclonal Antibodies

Nipocalimab for Lupus Nephritis

Q: What is the mechanism of action of this treatment?

Common treatments for Lupus Nephritis (LN) include corticosteroids, cyclophosphamide, and mycophenolate mofetil, which suppress the immune system to reduce inflammation and prevent kidney damage. Nipocalimab, a novel treatment under study, inhibits the neonatal Fc receptor (FcRn) to reduce pathogenic IgG antibodies. This targeted approach is significant for LN patients as it addresses the root cause of the immune response, potentially offering more effective treatment with fewer side effects compared to traditional immunosuppressive therapies.

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

COVID-19 infection: During the 6 weeks prior to baseline, have had any of the following (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features of COVID-19 without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection

Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24 and week 52

Summary

This trial is testing nipocalimab, a medicine that reduces harmful antibodies, in patients with active Lupus Nephritis, a severe kidney condition caused by lupus. The study will last over a year and will monitor safety and effectiveness.

Who is the study for?

Adults with active Lupus Nephritis can join this trial. They should be up-to-date on vaccinations, taking a stable dose of prednisone (<=60 mg/day), and have had a kidney biopsy showing specific types of nephritis within the last 6 months. Participants must not have certain infections or other inflammatory diseases, nor received cyclophosphamide recently.

What is being tested?

The study is testing the effectiveness of Nipocalimab compared to a placebo in treating Lupus Nephritis. All participants will continue their standard-of-care treatment alongside either Nipocalimab or placebo to see if there's an improvement in their condition.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions similar to other immune therapies such as infusion-related reactions, increased risk of infections, and possible interference with normal immune responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had COVID-19 or been in close contact with someone who has in the last 6 weeks.

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I do not have conditions like RA, PsA, lupus, psoriasis, Crohn's disease, or active Lyme disease.

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I have had infections like histoplasmosis or coccidioidomycosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Complete Renal Response (CRR)

Secondary study objectives

Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])

Percentage of Participants Achieving CRR

Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions

Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.

Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions

Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.

Group III: Group 1: PlaceboPlacebo Group2 Interventions

Participants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~420

Standard-of-care treatment

2018

N/A

~120

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus Nephritis (LN) include corticosteroids, cyclophosphamide, and mycophenolate mofetil, which suppress the immune system to reduce inflammation and prevent kidney damage. Nipocalimab, a novel treatment under study, inhibits the neonatal Fc receptor (FcRn) to reduce pathogenic IgG antibodies. This targeted approach is significant for LN patients as it addresses the root cause of the immune response, potentially offering more effective treatment with fewer side effects compared to traditional immunosuppressive therapies.