What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include acetylcholinesterase inhibitors, immunosuppressants, and intravenous immunoglobulin (IVIG) therapy. Acetylcholinesterase inhibitors can cause gastrointestinal issues, muscle cramps, and increased salivation. Immunosuppressants like prednisone and azathioprine may lead to side effects such as weight gain, hypertension, diabetes, and increased infection risk. IVIG therapy, which is similar to the IgG modulation studied with nipocalimab, can cause headaches, fever, chills, and in rare cases, thromboembolic events and renal dysfunction. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, including acetylcholinesterase inhibitors like pyridostigmine, which provide symptomatic relief. Immunosuppressants such as azathioprine, mycophenolate mofetil, and cyclosporine are also used to manage the disease. More recently, monoclonal antibodies like eculizumab, which targets the complement system, have been approved for patients with refractory generalized MG. While specific FDA approvals for IgG modulation in MG are not detailed, treatments like intravenous immunoglobulin (IVIg) are commonly used to modulate immune response in MG patients.

What other types of research exist?

Promising novel alternatives to Nipocalimab for Myasthenia Gravis patients include: 1) Efgartigimod, an FcRn antagonist that reduces IgG levels and has shown efficacy in clinical trials. 2) Rituximab, a monoclonal antibody targeting CD20-positive B cells, which has been used off-label with positive outcomes. 3) Rozanolixizumab, another FcRn antagonist currently in clinical trials, showing potential in reducing pathogenic IgG. These alternatives offer different mechanisms of action and have shown promise in clinical studies for MG treatment.

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Monoclonal Antibodies

Nipocalimab for Myasthenia Gravis

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

The most common treatments for Myasthenia Gravis (MG) include immunosuppressants, acetylcholinesterase inhibitors, and therapies targeting immunoglobulin G (IgG). Immunosuppressants, such as corticosteroids and azathioprine, reduce the overall immune response, thereby decreasing the production of autoantibodies that attack acetylcholine receptors. Acetylcholinesterase inhibitors, like pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. IgG modulation therapies, such as intravenous immunoglobulin (IVIG) and emerging treatments like Nipocalimab, work by altering the activity or levels of IgG antibodies, which are responsible for the autoimmune attack in MG. These treatments are crucial as they directly address the underlying immune dysfunction, providing symptom relief and improving the quality of life for MG patients.

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

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 IIa/b, IIIa/b, or IVa/b at screening

Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening

Must not have

Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nipocalimab, a medication that lowers certain antibodies, in children and teens with generalized myasthenia gravis who don't respond well to standard treatments. The goal is to see if it helps reduce their symptoms by lowering harmful antibodies in their blood.

Who is the study for?

This trial is for children aged 2 to less than 18 with generalized myasthenia gravis (gMG), who have not responded well to standard treatments. They must meet specific clinical criteria, have certain antibodies present, and maintain a stable use of any herbal or nutritional supplements. Participants need proper venous access for infusions and blood sampling, be within the normal weight range for their age and sex, and females able to bear children must test negative for pregnancy.

What is being tested?

The study tests Nipocalimab's effects on total serum immunoglobulin G (IgG) levels in pediatric patients with gMG. It aims to assess the safety, tolerability, and pharmacokinetics of Nipocalimab in these young participants who are already receiving standard care but need additional treatment.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with monoclonal antibody therapies like Nipocalimab may include allergic reactions such as rash or itching, potential infusion-related reactions like fever or chills, fatigue, headache, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with generalized myasthenia gravis.

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I tested positive for specific antibodies related to my muscle condition.

Select...

My veins can be used for giving medication and taking blood samples.

Exclusion Criteria

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

Select...

I do not have an immunodeficiency unrelated to my myasthenia gravis treatment.

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I have had or will have surgery to remove my thymus gland within a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels

Clearance (CL) of Nipocalimab

Half-life (t1/2) of Nipocalimab

+11 more

Secondary study objectives

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

Change in the Quantitative Myasthenia Gravis (QMG) Score

European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NipocalimabExperimental Treatment1 Intervention

Participants age 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for US sites only) will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~420

0 / 5Eligibility 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

The most common treatments for Myasthenia Gravis (MG) include immunosuppressants, acetylcholinesterase inhibitors, and therapies targeting immunoglobulin G (IgG). Immunosuppressants, such as corticosteroids and azathioprine, reduce the overall immune response, thereby decreasing the production of autoantibodies that attack acetylcholine receptors. Acetylcholinesterase inhibitors, like pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. IgG modulation therapies, such as intravenous immunoglobulin (IVIG) and emerging treatments like Nipocalimab, work by altering the activity or levels of IgG antibodies, which are responsible for the autoimmune attack in MG. These treatments are crucial as they directly address the underlying immune dysfunction, providing symptom relief and improving the quality of life for MG patients.

Update in immunosuppressive therapy of myasthenia gravis.