Efgartigimod for Myasthenia Gravis
(ADAPT NXT Trial)

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

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

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

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Exclusion Criteria

You have had a bad reaction to efgartigimod or any of its ingredients before.

You have another autoimmune disease that might make it hard to understand the symptoms of the condition being studied or put you at risk.

Previous participation in a clinical study or patient access program during which they were treated with efgartigimod

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Treatment Details

Interventions

Efgartigimod (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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)

Efgartigimod is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Vyvgart for: