What side effects are associated with this type of intervention?

Common treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) include intravenous immunoglobulin (IVIg), corticosteroids, and plasmapheresis. IVIg is generally well-tolerated but can cause side effects such as headaches, fever, chills, and, rarely, aseptic meningitis. Corticosteroids can lead to weight gain, hypertension, diabetes, osteoporosis, and increased infection risk. Plasmapheresis may cause low blood pressure, infection, and blood clotting issues. Treatments similar to nipocalimab, such as other immunomodulatory therapies, may also carry risks of infections and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), primarily focusing on immunotherapy. These include intravenous immunoglobulin (IVIg), corticosteroids, and plasma exchange (plasmapheresis). IVIg is commonly used and works by modulating the immune system. Corticosteroids reduce inflammation and immune activity, while plasma exchange removes antibodies from the blood. Although not specifically mentioned in the provided context, treatments like rituximab, which targets B-cells, have also been used off-label for CIDP. Nipocalimab, an Anti-FcRn antibody, is being studied for its potential to reduce pathogenic IgG antibodies, offering a novel approach similar to existing immunotherapies.

What other types of research exist?

Promising alternatives to Nipocalimab for CIDP patients include Rituximab and intravenous immunoglobulin (IVIg). Both have shown efficacy in treating various neuropathies and demyelinating conditions.

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Monoclonal Antibodies

Nipocalimab for CIDP

Phase 2 & 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up stage a: 12 weeks; stage b: up to 52 weeks

Summary

This trial is testing nipocalimab, a medicine that helps the immune system, in adults with CIDP who initially respond to it. The goal is to see if it can safely and effectively delay the return of symptoms by blocking harmful immune actions.

Who is the study for?

Adults over 18 with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as per EAN/PNS criteria, showing active disease. They must have an INCAT disability score of 2-9 and be willing to stop or taper current treatments like corticosteroids or immunoglobulins. Excluded are those with severe disorders, pure sensory CIDP, other diseases that explain symptoms better, known allergies to nipocalimab or its components.

What is being tested?

The trial is testing the effectiveness of Nipocalimab in preventing relapse in adults with CIDP who responded initially to the drug during Stage A. Participants will either receive Nipocalimab or a placebo to compare outcomes.

What are the potential side effects?

While specific side effects for Nipocalimab aren't listed here, common ones for similar drugs include allergic reactions at the infusion site, potential organ inflammation due to immune response changes, and general discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ stage a: 12 weeks; stage b: up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~stage a: 12 weeks; stage b: up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and stage a: 12 weeks; stage b: up to 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Stage B: Time to First Occurrence of a Relapse Event

Secondary study objectives

Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time

Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab

Number of Participants with Change in Clinical Laboratory Values Over Time

+26 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NipocalimabExperimental Treatment1 Intervention

Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.

Group II: PlaceboPlacebo Group1 Intervention

Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~520

Do I qualify?Apply below to find out

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

The most common treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) include glucocorticoids, intravenous immunoglobulin (IVIG), and plasma exchange. Glucocorticoids work by reducing inflammation and suppressing the immune system, which helps to prevent further damage to the myelin sheath. IVIG provides a high dose of normal antibodies that can modulate the immune system and reduce its attack on the nerves. Plasma exchange removes harmful antibodies from the blood, thereby reducing immune-mediated damage. Nipocalimab, an anti-FcRn antibody, works by blocking the neonatal Fc receptor (FcRn), which is responsible for recycling IgG antibodies. This leads to a reduction in the levels of pathogenic IgG antibodies. These treatments are crucial for CIDP patients as they help to halt the immune attack on the peripheral nerves, thereby preventing further demyelination and promoting recovery.