What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly those involving immunomodulation and monoclonal antibodies like nipocalimab and anifrolumab, can have side effects such as infusion reactions, increased risk of infections, and hypersensitivity reactions. Anifrolumab, which targets type I interferon receptors, has shown a consistent safety profile, but small sample sizes in some studies limit definitive conclusions. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for lupus, including biologics and small molecules. Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), was the first biologic approved for lupus. More recently, anifrolumab, which targets the type I interferon receptor, has also been approved. While these treatments do not specifically target the neonatal Fc receptor (FcRn) like nipocalimab, they represent significant advancements in biologic therapies for lupus. Other treatments in development aim to restore immunological balance and tolerance, potentially offering more tailored options for lupus patients in the future.

What other types of research exist?

Promising novel alternatives to Nipocalimab for Lupus patients include Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS). Both therapies have shown efficacy in reducing disease activity in SLE patients and are considered significant advancements in the treatment landscape.

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Monoclonal Antibodies

Nipocalimab for Lupus

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

Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization

Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

Must not have

Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications

Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 58

Summary

This trial is testing nipocalimab, a special medicine that blocks harmful parts of the immune system, in people with active lupus. The goal is to see if it can reduce inflammation and prevent further damage caused by the disease.

Who is the study for?

Adults diagnosed with systemic lupus erythematosus (SLE) for at least 6 months, meeting specific criteria including positive autoantibody tests and a certain level of disease activity. Participants must be on stable doses of standard SLE treatments but cannot have severe kidney issues or recent severe infections.

What is being tested?

The trial is testing the effectiveness of Nipocalimab compared to a placebo in adults with active SLE. Participants will continue their standard-of-care treatment while receiving either the study drug or placebo to see if there's an improvement in their condition.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions similar to other immune-modulating drugs such as infusion-related reactions, increased risk of infections, and possible impacts on blood counts or organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lupus is active, with a SLEDAI-2K score of 6 or more.

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I am currently on a stable dose of glucocorticoids, antimalarials, or up to 2 immunomodulatory drugs.

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I have been diagnosed with lupus for at least 6 months and meet specific lupus criteria.

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I have severe skin lupus or at least 4 painful and inflamed joints.

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I have a positive test for specific autoantibodies related to my condition.

Exclusion Criteria

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

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My lupus symptoms are worsening and might need stronger treatment soon.

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I have not had a severe infection or been hospitalized for one in the last 8 weeks.

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I do not have any inflammatory diseases that could affect the trial's results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 58

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 58

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 58 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 an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24

Secondary study objectives

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

Number of Participants with Change from Baseline in Laboratory Parameters Over Time

Number of Participants with Change from Baseline in Vital Signs Parameters Over Time

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

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

Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

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

Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Group III: Group 1: PlaceboPlacebo Group2 Interventions

Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids \[GCs\]).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~520

Standard-of-care treatment

2018

N/A

~120

0 / 8Eligibility 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, such as nipocalimab, work by targeting specific pathways involved in the disease's pathogenesis. Nipocalimab inhibits the neonatal Fc receptor (FcRn), which reduces the levels of pathogenic autoantibodies that contribute to lupus symptoms. Other treatments include belimumab, which targets B lymphocytes to reduce their activity, and various biologics that inhibit cytokines like interferon, reducing inflammation. These mechanisms are crucial for lupus patients as they help control the overactive immune response, reduce disease activity, and prevent organ damage, thereby improving quality of life and long-term outcomes.

The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles.Unmet Needs in the Pathogenesis and Treatment of Systemic Lupus Erythematosus.