What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis, including FcRn inhibitors like Efgartigimod, often have side effects such as headaches, nasopharyngitis, and mild gastrointestinal issues like diarrhea. Other treatments for Myasthenia Gravis may also cause muscle-related symptoms, fatigue, dizziness, and injection-site reactions. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, including acetylcholinesterase inhibitors like pyridostigmine, immunosuppressants such as azathioprine and mycophenolate mofetil, and monoclonal antibodies like eculizumab, which targets the complement system. Efgartigimod, an FcRn inhibitor, represents a newer approach by reducing pathogenic IgG antibodies. This mechanism is distinct from traditional therapies and offers a novel treatment option for patients with generalized Myasthenia Gravis.

What other types of research exist?

Promising novel alternatives to Efgartigimod for Myasthenia Gravis patients include: 1) Rozanolixizumab, another FcRn inhibitor with a different administration route; 2) Ravulizumab, a complement inhibitor that targets the C5 protein; 3) Zilucoplan, a subcutaneous complement inhibitor; and 4) Rituximab, a monoclonal antibody targeting CD20 on B cells. These treatments have shown efficacy in clinical trials and offer different mechanisms of action for managing MG.

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Monoclonal Antibodies

Long-term Safety of Efgartigimod for Myasthenia Gravis (ADAPT Jr + Trial)

Phase 2 & 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

Female adolescents of childbearing potential must have a negative urine pregnancy test at trial entry

Be younger than 65 years old

Must not have

Known autoimmune disease or any condition that would interfere with assessment of gMG symptoms or put the participant at risk

Clinically significant uncontrolled chronic infections at study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing the long-term safety of two forms of a medication called efgartigimod, given either through a drip or as an injection. It is aimed at patients with generalized Myasthenia Gravis, a condition that causes muscle weakness. The medication works by lowering harmful proteins in the blood that attack muscles.

Who is the study for?

This trial is for children who have a muscle weakness condition called generalized myasthenia gravis and were part of an earlier study (ARGX-113-2006). They must not plan to donate sperm or become pregnant, agree to use contraception, and understand the trial's requirements. Those with hypersensitivity to efgartigimod, recent live vaccines, other autoimmune diseases, or uncontrolled infections cannot join.

What is being tested?

The trial is testing the long-term safety of a medication called Efgartigimod IV in children who previously participated in another related study. It aims to ensure that this treatment continues to be safe over an extended period.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions due to hypersensitivity to efgartigimod or its components. Participants will be monitored for any adverse events throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am a female of childbearing age and my pregnancy test before the trial was negative.

Exclusion Criteria

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

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I do not have an autoimmune disease or any condition that could affect my gMG symptoms or increase my risk.

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I do not have any uncontrolled chronic infections.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Efgartigimod or Efgartigimod PH20 SCExperimental Treatment1 Intervention

Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment

0 / 4Eligibility 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 acetylcholinesterase inhibitors, immunosuppressive drugs, and emerging therapies like FcRn inhibitors. Acetylcholinesterase inhibitors, such as pyridostigmine, work by increasing the amount of acetylcholine at the neuromuscular junction, thereby improving muscle contraction. Immunosuppressive drugs, including corticosteroids and other agents like azathioprine, reduce the immune system's attack on acetylcholine receptors. Emerging treatments like FcRn inhibitors, such as efgartigimod, lower the levels of pathogenic IgG antibodies by blocking the neonatal Fc receptor (FcRn), which is responsible for recycling IgG. This reduction in antibodies can lead to decreased muscle weakness and improved symptoms. These treatments are crucial for MG patients as they target different aspects of the disease's pathophysiology, offering symptomatic relief and potentially modifying the disease course.

Update in immunosuppressive therapy of myasthenia gravis.Antagonism of the Neonatal Fc Receptor as an Emerging Treatment for Myasthenia Gravis.

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Who is running the clinical trial?

argenxLead Sponsor

67 Previous Clinical Trials

10,362 Total Patients Enrolled

14 Trials studying Myasthenia Gravis

4,768 Patients Enrolled for Myasthenia Gravis

Media Library

Efgartigimod IV (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05374590 — Phase 2 & 3

Myasthenia Gravis Research Study Groups: Efgartigimod or Efgartigimod PH20 SC

Myasthenia Gravis Clinical Trial 2023: Efgartigimod IV Highlights & Side Effects. Trial Name: NCT05374590 — Phase 2 & 3

Efgartigimod IV (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374590 — Phase 2 & 3

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