Efgartigimod for Myasthenia Gravis
(ADAPT NXT Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
You may not need to stop your current medications for Generalized Myasthenia Gravis, as the trial allows certain treatments like nonsteroidal immunosuppressive drugs, steroids, and acetylcholinesterase inhibitors if they are stable for at least a month before screening. However, some specific treatments like intravenous immunoglobulin, rituximab, and eculizumab must be stopped for a certain period before starting the trial.
Is efgartigimod safe for humans?
How is the drug efgartigimod different from other treatments for myasthenia gravis?
What data supports the effectiveness of the drug Efgartigimod for Myasthenia Gravis?
Efgartigimod has been shown in clinical trials to significantly reduce disease symptoms and improve muscle strength and quality of life in patients with generalized myasthenia gravis. It is approved in several countries and has demonstrated consistent and meaningful improvements in patients, with most side effects being mild to moderate.12357
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Regimen Comparison
Participants receive either a continuous or cyclic regimen of efgartigimod to evaluate efficacy, safety, and tolerability
Extension
Participants continue treatment to further assess long-term efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Efgartigimod
Efgartigimod is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University