What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis that reduce pathogenic IgG antibodies, such as intravenous immunoglobulin (IVIG), can have several side effects. These include mild reactions like headache, chills, dizziness, and fluid retention. More serious but less common side effects include aseptic meningitis, acute renal failure, thrombotic events (such as myocardial infarction, stroke, and pulmonary embolism), and anaphylaxis, particularly in patients with immunoglobulin A (IgA) deficiency. The risk of acute nephrotoxicity is higher in patients with underlying renal insufficiency and is related to the high sucrose content in some IVIG preparations.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis that target pathogenic antibodies. Intravenous immunoglobulin (IVIG) and plasmapheresis are commonly used to reduce circulating antibodies and provide rapid symptom relief. More recently, monoclonal antibodies like Rituximab, which targets CD20 on B cells, have been used off-label for their ability to reduce antibody production. Efgartigimod, currently under investigation, works by reducing pathogenic IgG antibodies, similar to these existing therapies, but with a potentially more targeted mechanism.

What other types of research exist?

Promising novel alternatives to Efgartigimod for Myasthenia Gravis patients include other monoclonal antibodies (mAbs) currently under investigation, such as Rituximab, which targets CD20 on B cells, and complement inhibitors like Eculizumab, which inhibits the complement system. These therapies have shown encouraging preliminary results and offer potential for better outcomes in MG treatment.

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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis (ADAPT NXT Trial)

Phase 3

Waitlist Available

Research Sponsored by argenx

Eligibility Criteria Checklist

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

Must have

Has a Myasthenia Gravis - Activities of Daily Living (MG-ADL) total score ≥5 at screening and the day 1 visit, with more than 50% of the score due to nonocular symptoms

Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs)

Must not have

Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening

A thymectomy within 3 months of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called efgartigimod to help people with Generalized Myasthenia Gravis, a condition that causes muscle weakness. The medication works by lowering harmful proteins in the blood that attack muscles. The study will compare different usage patterns of the medication over a period of several months. Efgartigimod was well tolerated and effective in patients with generalized myasthenia gravis.

Who is the study for?

Adults diagnosed with Generalized Myasthenia Gravis (gMG) who have muscle weakness and are positive for anti-acetylcholine receptor antibodies. Participants must be able to consent, follow study procedures, and use contraception if applicable. Excluded are those with serious diseases, recent major surgery, pregnancy or lactation, certain prior treatments including efgartigimod itself, active infections including COVID-19, other autoimmune diseases that could interfere with the study or pose a risk.

What is being tested?

The trial is testing Efgartigimod IV's effectiveness in two dosing regimens: continuous versus cyclic. It aims to determine which regimen offers better efficacy while assessing safety over a period of up to 138 weeks. The first part compares regimens over 21 weeks; the second extends treatment up to an additional 105 weeks.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to Efgartigimod IV administration throughout the trial duration. Side effects may include typical infusion-related responses such as allergic reactions or site irritation.

Eligibility Criteria

Inclusion Criteria

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

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My daily activities are significantly affected by my Myasthenia Gravis symptoms.

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I have been diagnosed with gMG and tested positive for AChR antibodies.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have any serious ongoing infections.

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I had my thymus gland removed within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: efgartigimod IV - IIExperimental Treatment1 Intervention

Patients receiving efgartigimod IV treatment (Cyclic regimen: efgartigimod 10 mg/kg q7d for a total of 4 infusions per TP for 2 TPs with a fixed 4-week IP between each TP)

Group II: efgartigimod IV - IExperimental Treatment1 Intervention

Patients receiving efgartigimod IV treatment (Continuous regimen: efgartigimod 10 mg/kg q2w)

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) primarily aim to reduce the levels of pathogenic antibodies that attack acetylcholine receptors at the neuromuscular junction. Efgartigimod, for example, works by reducing pathogenic IgG antibodies, thereby decreasing the immune system's attack on these receptors. This is crucial for MG patients as it directly addresses the underlying cause of muscle weakness and fatigue. Other treatments include acetylcholinesterase inhibitors, which increase the availability of acetylcholine, and immunosuppressants like corticosteroids and IVIG, which broadly suppress the immune response. These treatments help improve muscle strength and reduce symptoms, significantly enhancing the quality of life for MG patients.

Update in immunosuppressive therapy of myasthenia gravis.