What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis, such as intravenous immunoglobulin (IVIG), plasmapheresis, and monoclonal antibodies like rituximab, share some side effects. These include infusion reactions, infections, and allergic reactions. IVIG can cause headache, fever, chills, and muscle aches. Plasmapheresis may result in low blood pressure, bleeding, and infection risks. Rituximab can lead to infusion reactions, infections, and rarely, progressive multifocal leukoencephalopathy (PML).

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, including acetylcholinesterase inhibitors like pyridostigmine, which provide symptomatic relief. Immunosuppressive drugs such as azathioprine, mycophenolate mofetil, and cyclosporine are also used to manage the disease. More recently, monoclonal antibodies like eculizumab, which inhibits the complement system, have been approved for patients with refractory generalized Myasthenia Gravis. While not directly targeting FcRn, these treatments aim to reduce the autoimmune response, similar to the mechanism of nipocalimab.

What other types of research exist?

Promising novel alternatives to Nipocalimab for Myasthenia Gravis patients in 2024 include: 1) Efgartigimod, another FcRn inhibitor that has shown efficacy in reducing pathogenic IgG antibodies. 2) Rituximab, a monoclonal antibody targeting CD20+ B cells, which has been used in various autoimmune conditions. 3) Eculizumab, a complement inhibitor that has been approved for MG and works by inhibiting the complement cascade involved in the disease pathology.

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Monoclonal Antibodies

Nipocalimab for Myasthenia Gravis

Phase 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

Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol

Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening

Must not have

Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)

Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years and 8 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing nipocalimab, a medicine that blocks harmful proteins, in people with generalized myasthenia gravis to see if it can reduce their muscle weakness.

Who is the study for?

Adults with generalized myasthenia gravis (MG) who have a certain level of muscle weakness and can undergo infusions and blood sampling. Women must not be pregnant, and men agree to not donate sperm during the study. Participants should not have had recent thymectomy or MG crisis, nor should they have heart issues or allergies to the trial drug.

What is being tested?

The trial is testing nipocalimab's effectiveness compared to a placebo in improving symptoms of generalized myasthenia gravis. Patients will receive either the actual medication or a placebo without knowing which one they are getting.

What are the potential side effects?

While specific side effects for nipocalimab aren't listed here, common ones may include reactions at the infusion site, potential allergic responses, general discomfort, fatigue, and possibly changes in immune system function.

Eligibility Criteria

Inclusion Criteria

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

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I can receive medication through a vein and provide blood samples as needed.

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I have been diagnosed with generalized myasthenia gravis.

Exclusion Criteria

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

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I have mild or very severe myasthenia gravis, or had a crisis recently.

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I had my thymus gland removed within the last year or plan to have it removed.

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I have had a heart attack, unstable heart disease, or stroke in the last 3 months.

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I do not have an immunodeficiency unrelated to my gMG treatment, nor a family history of it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 8 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Average Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score

Secondary study objectives

Nervous system disorder

Average Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score Over Weeks 22 And 24 of the Double-blind Placebo-controlled Phase

Average Change in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 of the Double-blind Placebo-controlled Phase

+25 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NipocalimabExperimental Treatment1 Intervention

Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion till study end.

Group II: PlaceboPlacebo Group1 Intervention

Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~420

0 / 6Eligibility 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 Myasthenia Gravis (MG) include acetylcholinesterase inhibitors, immunosuppressive therapies, and emerging treatments like FcRn inhibitors. Acetylcholinesterase inhibitors, such as pyridostigmine, enhance neuromuscular transmission by preventing the breakdown of acetylcholine. Immunosuppressive therapies, including corticosteroids and azathioprine, reduce the immune system's attack on the neuromuscular junction. Emerging treatments like nipocalimab inhibit the neonatal Fc receptor (FcRn) to lower pathogenic IgG antibodies, which are responsible for the autoimmune attack in MG. These mechanisms are vital for MG patients as they help in effectively managing symptoms and improving quality of life.

Update in immunosuppressive therapy of myasthenia gravis.