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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
No Placebo-Only Group

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 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.

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

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.

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
11,004 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,785 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
~7 spots leftby Sep 2028